{"id":11559,"date":"2026-01-30T08:00:11","date_gmt":"2026-01-30T05:00:11","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=11559"},"modified":"2026-01-30T09:54:17","modified_gmt":"2026-01-30T06:54:17","slug":"certificate-de-conformitate-ce-falsificate-copii-falsificate-ale-unor-certificate-de-conformitate-ce-emise-de-organisme-notificate","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/certificate-de-conformitate-ce-falsificate-copii-falsificate-ale-unor-certificate-de-conformitate-ce-emise-de-organisme-notificate\/","title":{"rendered":"Falsified EC certificates of conformity \/ Falsified copies of EC certificates of conformity issued by Notified Bodies"},"content":{"rendered":"<div class=\"anunturi\"><ul class=\"display-posts-listing\"><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-30-03-2026-3\/\">Important notification<\/a><div class=\"content\"><p><strong>30.03.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type \u2018Aneroid Sphygmomanometer\u2019 accompanied by a falsified copy of CE certificate of conformity no. G2M 067329 0010 Rev. 01, presumably issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2020-12-17 and valid until 2025-10-01 .<br \/>\n<strong>The valid CE Certificate of Conformity with No. G2M 067329 0010 Rev. 01, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2018-12-17, valid until 2023-10-01 for \u2018Aneroid Sphygmomanometer\u2019 and belongs to manufacturer Wenzhou Kangju Medical Instrument Co. Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell \u2018Aneroid Sphygmomanometer\u2019 on the Romanian territory, based on a falsified copy of certificate no. G2M 067329 0010 Rev. 01, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 The Market Surveillance Service, using the contact details posted on the NAMMDR website.<br \/>\nFor your own verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-30-03-2026-2\/\">Important notification<\/a><div class=\"content\"><p><strong>30.03.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type \u2018Fetal Dopplers, Pulse Oximeters, Nebulizers and Infrared Thermometers\u2019 accompanied by a falsified copy of CE certificate of conformity no. G1 073767 0013 Rev. 00, presumably issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2021-02-03 and valid until 2026-02-02.<br \/>\n<strong>The valid CE Certificate of Conformity with No. G1 073767 0013 Rev. 00, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2019-02-03, valid until 2024 -02-02 for \u2018Fetal Dopplers, Pulse Oximeters, Nebulizers and Infrared Thermometers\u2019 and belongs to manufacturer Shenzhen Aeon Technology Co. Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell \u2018Fetal Dopplers, Pulse Oximeters, Nebulizers and Infrared Thermometers \u2018 on the Romanian territory, based on a falsified copy of certificate no. G1 073767 0013 Rev. 00, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 The Market Surveillance Service, using the contact details posted on the NAMMDR website.<br \/>\nFor your own verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-30-03-2026\/\">Important notification<\/a><div class=\"content\"><p><strong>30.03.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type \u2018Mechanical Sphygmomanometers and Pressure Infusion Cuffs\u2019 accompanied by a falsified copy of CE certificate of conformity no. G3M 020267 0020 Rev. 00, presumably issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 29-09-2021 and valid until 26-05-2026.<br \/>\n<strong>The valid CE Certificate of Conformity with No. G3M 020267 0020 Rev. 00, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2019-06-25, valid until 2024-05-26 for \u2018Mechanical Sphygmomanometers and Pressure Infusion Cuffs\u2019 and belongs to manufacturer Friedrich Bosch GmbH &#038; Co. KG, Germany.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell \u2018Mechanical Sphygmomanometers and Pressure Infusion Cuffs\u2019 on the Romanian territory, based on a falsified copy of certificate no. G3M 020267 0020 Rev. 00, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 The Market Surveillance Service, using the contact details posted on the NAMMDR website.<br \/>\nFor your own verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-09-02-2026\/\">Important notification<\/a><div class=\"content\"><p><strong>09.02.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type \u2018Laryngeal Mask Airways, Stomach Tubes, Drainage Tubes, Endotracheal Tubes, Oxygen Masks, Suction Catheters, Nasal Oxygen Cannulas, Breathing Circuits, Heat and Moisture Exchangers, Breathing System Filters, Manual Resuscitators, Wound Drainage Systems, Infusion Sets with Precision Filters for Single-Use, Double Lumen Endobronchial Tubes, Single-Use Anesthesia Kits, Urinary Catheterization Collection Kits, Disposable Endobronchial Blocker Tubes, Anesthesia Masks, Catheter Mounts, Suction Tubing with Yankauer Handle, Nebulizer Masks, Tracheostomy Tubes\u2019, accompanied by a falsified copy of CE certificate of conformity no. G2.086250.0018 Rev.01, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2022-01-06 and valid until 2027-05-26.<br \/>\n<strong>The valid CE Certificate of Conformity with No. G2.086250.0018 Rev.01 was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2020-01-08, valid until 2024-05-26, for \u2018Laryngeal Mask Airways, Stomach Tubes, Drainage Tubes, Endotracheal Tubes, Oxygen Masks, Suction Catheters, Nasal Oxygen Cannulas, Breathing Circuits, Heat and Moisture Exchangers, Breathing System Filters, Manual Resuscitators, Wound Drainage Systems, Infusion Sets with Precision Filters for Single-Use, Double Lumen Endobronchial Tubes, Single-Use Anesthesia Kits, Urinary Catheterization Collection Kits, Disposable Endobronchial Blocker Tubes, Anesthesia Masks, Catheter Mounts, Suction Tubing with Yankauer Handle, Nebulizer Masks, Tracheostomy Tubes\u2019 and belongs to manufacturer Ningbo Luke Medical Devices Co., Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell \u2018Laryngeal Mask Airways, Stomach Tubes, Drainage Tubes, Endotracheal Tubes, Oxygen Masks, Suction Catheters, Nasal Oxygen Cannulas, Breathing<br \/>\nCircuits, Heat and Moisture Exchangers, Breathing System Filters, Manual Resuscitators, Wound Drainage Systems, Infusion Sets with Precision Filters for Single-Use, Double Lumen Endobronchial Tubes,<br \/>\nSingle-Use Anesthesia Kits, Urinary Catheterization Collection Kits, Disposable Endobronchial Blocker Tubes, Anesthesia Masks, Catheter Mounts, Suction Tubing with Yankauer Handle, Nebulizer Masks,<br \/>\nTracheostomy Tubes\u2019 on the Romanian territory based on a falsified copy of certificate no. G2.086250.0018 Rev.01, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service, using the contact details posted on the NAMMDR website.<br \/>\nFor your own verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-02-02-2026\/\">Important notification<\/a><div class=\"content\"><p><strong>02.02.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market \u2018Dental Unit\u2019 if, for these medical devices, they have come into possession of the falsified copy of the CE certificate of conformity no. G2 17 02 83445 004 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2019-07-10, valid until 2025-07-09, for any other manufacturer except for Foshan Hongke Medical Instrument Factory, China.<br \/>\n<strong>The valid CE Certificate of Conformity with No. G2 17 02 83445 004 was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2017-07-10, valid until 2022-07-09 for \u2018Dental Unit\u2019 and belongs to manufacturer Foshan Hongke Medical Instrument Factory, China.<\/strong><br \/>\nIf you have come into possession of such medical devices for which you were shown the falsified copy of the CE certificate of conformity no. G2 17 02 83445 004, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor your own verification, we recommend that interested parties consult the information posted on the website of the Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-29-01-2026-2\/\">Important notification<\/a><div class=\"content\"><p><strong>29.01.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market Computed Tomography Scanner Systems, X-ray Imaging Systems, Magnetic Resonance Imaging Systems, Positron Emission Tomography(PET) and Computed Tomography(CT) Systems, Diagnostic Ultrasound Systems, Diagnostic X-ray High Voltage Generators, Picture Archiving and Communication Systems accompanied by a falsified copy of CE certificate of conformity no. G1.098883.0002.Rev.02, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2024-06-03 and valid until 2026-06-02.<br \/>\n<strong>The valid CE Certificate of Conformity with No. G1.098883.0002 Rev.02 was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2019-09-03, valid until 2024-05-26 for \u2018Computed Tomography Scanner Systems, X-ray Imaging Systems, Magnetic Resonance Imaging Systems, Positron Emission Tomography(PET) and Computed Tomography(CT) Systems, Diagnostic Ultrasound Systems, Diagnostic X-ray High Voltage Generators, Picture Archiving and Communication Systems\u2019 and belongs to manufacturer Neusoft Medical Systems Co., Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell \u2018Computed Tomography Scanner Systems, X-ray Imaging Systems, Magnetic Resonance Imaging Systems, Positron Emission Tomography(PET) and Computed Tomography(CT) Systems, Diagnostic Ultrasound Systems, Diagnostic X-ray High Voltage Generators, Picture Archiving and Communication Systems\u2019 on Romanian territory, based on the falsified copy of the CE certificate of conformity no. G1.098883.0002 Rev.02, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-29-01-2026\/\">Important notification<\/a><div class=\"content\"><p><strong>29.01.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market \u2018Human chorionic gonadotropin Colloidal gold test, Human Luteinizing hormone Colloidal gold test, Fecal Occult Blood Colloidal gold test\u2019 accompanied by a falsified copy of CE certificate of conformity no. V1 084924 0002 Rev. 02, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2018-11-30 and valid until 2025-10-10.<br \/>\n<strong>The valid CE Certificate of Conformity with No. V1.084924.0002.Rev.01 was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2018-11-30, valid until 2023-10-10 for \u2018Human chorionic gonadotropin Colloidal gold test, Human Luteinizing hormone Colloidal gold test, Fecal Occult Blood Colloidal gold\u2019 test and belongs to manufacturer Hubei MEIBAO Biotechnology Co., Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell \u2018Human chorionic gonadotropin Colloidal gold test, Human Luteinizing hormone Colloidal gold test, Fecal Occult Blood Colloidal gold test\u2019 on the Romanian territory based on the falsified copy of the CE certificate of conformity no. V1.084924.0002.Rev.01, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-23-01-2026\/\">Important notification<\/a><div class=\"content\"><p><strong>23.01.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market \u2018Sterile Non-active Medical Devices\u2019 manufactured by Guangzhou AMK Medical Equipment Co., Ltd., China for which they have come into possession of the falsified copy of the EC certificate of conformity no. G2 001281 0001 Rev. 02, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2021-04-29 and valid until 2025-05-26 for this manufacturer.<br \/>\n<strong>The valid CE Certificate of Conformity with No. G2 001281 0001 Rev. 02 was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2020-04-29, valid until 2024-05-26 for Sterile Non-active Medical Devices and belongs to manufacturer Guangzhou AMK Medical Equipment Co., Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell Sterile Non-active Medical Devices on the Romanian territory based on a falsified copy of certificate no. G2 001281 0001 Rev.02, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service, using the contact details posted on the NAMMDR website.<br \/>\nFor your own verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-19-01-2026\/\">Important notification<\/a><div class=\"content\"><p><strong>19.01.2026<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices type \u2018Infusion Set, Lap Sponges, Sterile Medication Set, Gauze Swabs without X-ray Thread, Gauze Swabs with X-ray, Non-woven Swabs with X-ray Thread\u2019, manufactured by Bluemed Healthcare Co., Ltd., China, for which they came into possession of the falsified copy of CE certificate of conformity no. G2 17 07 99160 003, which was allegedly issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2017-11-17 and valid until 2024-11-16 for this manufacturer.<br \/>\n<strong>The valid CE Certificate of Conformity with No. G2 17 07 99160 003 was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2017-11-17, valid until 2022-11-16 for \u2018Infusion Set, Lap Sponges, Gauze Swabs without X-ray Thread, Gauze Swabs with X-ray, Sterile Non-woven Swabs with X-ray Thread\u2019 and belongs to manufacturer Bluemed Healthcare Co., Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory \u2018Infusion Set, Lap Sponges, Sterile Medication Set, Gauze Swabs without X-ray Thread, Gauze Swabs with X-ray, Non-woven Swabs with X-ray Thread\u2019 based on the falsified copy of certificate no. G2 17 07 99160 003, do not use them and notify the National Agency for Medicines and Medical Devices of Romania &#8211; the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nDatabase of issued certificates: For your own verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-19-06-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>19.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type <strong>\u2018Infusion Sets for Single Use (with Needle), Sterile Hypodermic Syringes for Single Use (with Needle), Disposable Sterile Hypodermic Needles, Scalp vein Sets, Sterile Insulin Syringes for Single Use, Disposable Transfusion Set (with Needle), Urine Collection Bags\u2019<\/strong> accompanied by the falsified CE certificate no. Q6 073425 0011 Rev. 02, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2022-09-06 and valid until 2025-09-05.<br \/>\n<strong>The valid certificate with the same identification data, namely number, product categories, issue and expiry date belongs to manufacturer Jiangsu Zhengkang Medical Apparatus Co., Ltd., China and was issued by Certifying Body T\u00dcV S\u00dcD Product Service GmbH, Germany in accordance with the requirements of standard EN ISO 13485:2016 \u2013 Medical devices \u2014 Quality management systems \u2014 Requirements for regulatory purposes for \u2018Production and Distribution of Infusion Sets for Single Use (with Needle), Sterile Hypodermic Syringes for Single Use (with Needle), Disposable Sterile Hypodermic Needles, Scalp vein Sets, Sterile Insulin Syringes for Single Use, Disposable Transfusion Set (with Needle), Urine Collection Bags\u2019.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>\u2018Infusion Sets for Single Use (with Needle), Sterile Hypodermic Syringes for Single Use (with Needle), Disposable Sterile Hypodermic Needles, Scalp vein Sets, Sterile Insulin Syringes for Single Use, Disposable Transfusion Set (with Needle), Urine Collection Bags\u2019<\/strong> based on the falsified copy of certificate no. Q6 073425 0011 Rev. 02, do not use them and notify the National Agency for Medicines and Medical Devices of Romania &#8211; the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor your own verification, we recommend that interested parties consult the information posted on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-18-06-2025-3\/\">Important notification<\/a><div class=\"content\"><p><strong>18.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type <strong>\u2018Disposable Airways, Urine Bag, Vaginal Speculum, Sterile Wound Plaster\u2019<\/strong> accompanied by a falsified copy of CE certificate of conformity no. G2S 104356 0003 Rev.01, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2023-02-09 and valid until 2025-12-29.<br \/>\n<strong>The valid CE certificate of conformity with no. G2S 104356 0003 Rev.01 was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2021-05-03, valid until 2024-05-26, for \u2018Disposable Airways, Urine Bag, Vaginal Speculum, Sterile Wound Plaster\u2019 and belongs to manufacturer Ningbo Great Mountain Medical Instruments Co., Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell <strong>\u2018Disposable Airways, Urine Bag, Vaginal Speculum, Sterile Wound Plaster\u2019<\/strong> on the Romanian territory based on the falsified copy of the EC certificate of conformity no. G2S 104356 0003 Rev.01, do not use them and notify the National Agency for Medicines and Medical Devices of Romania &#8211; the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor your own verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-18-06-2025-2\/\">Important notification<\/a><div class=\"content\"><p><strong>18.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type <strong>\u2018Ligation Clips for Single Use\u2019<\/strong> accompanied by a falsified copy of CE certificate of conformity no. HD 60104799 0001, which would have been issued by Notified Body T\u00dcV Rheinland LGA Products GmbH, Germany (0197) on 2023-02-02 and valid until 2028-01-01.<br \/>\n<strong>The valid CE Certificate of Conformity with No. HD 60104799 0001, issued by Notified Body T\u00dcV Rheinland LGA Products GmbH, Germany (0197) on 2015-11-02, valid until 2018-06-03, for the same product category, belonged to manufacturer Tonglu Zhouji Medical Instrument Co., Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell <strong>\u2018Ligation Clips for Single Use\u2019 on the Romanian territory based on a falsified copy of the EC certificate of conformity no. HD 60104799 0001<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania &#8211; the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor your own verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV Rheinland LGA Products GmbH, Germany (0197), by accessing the links below:<br \/>\n\u2013 database with valid certificates: <a href=\"https:\/\/www.certipedia.com\/?locale=en\" target=\"_blank\">https:\/\/www.certipedia.com\/?locale=en<\/a><br \/>\n\u2013 database with falsified certificates: <a href=\"https:\/\/www.tuv.com\/world\/en\/warning-list\/\" target=\"_blank\">https:\/\/www.tuv.com\/world\/en\/warning-list\/<\/a> <\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-18-06-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>18.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\n18.06.2025<br \/>\nTo the attention of all importers, distributors and users of medical devices<br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type <strong>\u2018Pulse Oximeter, SPO2 Sensor, Patient Monitor\u2019<\/strong> accompanied by a falsified copy of CE certificate of conformity no. G1 087056 0005 Rev. 02, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2024-05-15 and valid until 2028-12-31.<br \/>\n<strong>The valid CE certificate of conformity with no. G1 087056 0005 Rev. 02 was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2019-05-16, valid until 2024-05-15, for \u2018SPO2 Monitor, Pulse Oximeter, Spo2 Sensor, Patient Monitor\u2019 and belongs to manufacturer Shanghai Berry Electronic Tech Co., Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell <strong>\u2018Pulse Oximeter, SPO2 Sensor, Patient Monitor\u2019<\/strong> on the Romanian territory based on the falsified copy of CE certificate of conformity no. G1 087056 0005 Rev. 02, do not use them and notify the National Agency for Medicines and Medical Devices of Romania &#8211; the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor your own verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-17-06-2025\/\">Important notification<\/a><div class=\"content\"><p><strong>17.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type <strong>\u2018Clinical Electronic Thermometers \u2013 Infrared Ear\/Forehead Thermometers \u2013 Infrared Ear Thermometers \u2013 Infrared Forehead Thermometers \u2013 Nerve and Muscle Stimulators \u2013 Electrical Acupuncture Stimulators \u2013 Transcutaneous Electrical Nerve Stimulators \u2013 Electrical Muscle Stimulators \u2013 Electrical Neuromuscular Incontinence Stimulators \u2013 Ultrasound Physical Therapy Devices \u2013 Ultrasound and Electrical Neuromuscular Stimulators \u2013 Magnetic Stimulators \u2013 Electromagnetic Stimulators \u2013 Stimulation Electrodes \u2013 Electromyograph (EMG) Biofeedback Device \u2013 Electromyograph (EMG) Biofeedback and Neuromuscular Stimulator \u2013 Shortwave Therapy Devices \u2013 Laser Therapy Devices\u2019 accompanied by a falsified copy of CE certificate of conformity no. HD 60147882 0001<\/strong>, which would have been issued by Notified Body T\u00dcV Rheinland LGA Products GmbH (0197) on 2021-06-03 and valid until 2025-06-21.<br \/>\n<strong>The valid EC Certificate of Conformity with No. HD 60147882 0001 HD 60147882 0001 was issued by Notified Body T\u00dcV Rheinland LGA Products GmbH (0197) on 2020-08-03, valid until 2024-05-26, for the same product categories, belonged to manufacturer Shenzhen Dongdixin Technology Co., Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>\u2018Clinical Electronic Thermometers &#8211; Infrared Ear\/Forehead Thermometers &#8211; Infrared Ear Thermometers &#8211; Infrared Forehead Thermometers &#8211; Nerve and Muscle Stimulators &#8211; Electrical Acupuncture Stimulators &#8211; Transcutaneous Electrical Nerve Stimulators &#8211; Electrical Muscle Stimulators &#8211; Electrical Neuromuscular Incontinence Stimulators &#8211; Ultrasound Physical Therapy Devices &#8211; Ultrasound and Electrical Neuromuscular Stimulators &#8211; Magnetic Stimulators &#8211; Electromagnetic Stimulators &#8211; Stimulation Electrodes &#8211; Electromyograph (EMG) Biofeedback Device &#8211; Electromyograph (EMG) Biofeedback and Neuromuscular Stimulator &#8211; Shortwave Therapy Devices &#8211; Laser Therapy Devices\u2019 based on the falsified copy of CE certificate of conformity no. HD 60147882 0001 HD 60147882 0001<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania &#8211; the Market Surveillance Service using the contact details posted on the NAMMDR website.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-19-08-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>19.08.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>\u2019Radio-Frequency assisted liposuction systems\u2019<\/strong> accompanied by the falsified copy of CE certificate of conformity no. 2120853CE01, which would have been issued by Notified Body DEKRA certification B.V., The Netherlands (0344) on 2022-02-01, revised on 2023-01-22 and valid until 2026-02-01.<br \/>\n<strong>The valid CE Certificate of Conformity with No. 2120853CE01, issued by Notified Body DEKRA certification B.V., The Netherlands (0344), on 2018-02-01, revised on 2020-01-27 and valid until 2023-02-01, for the same product categories, belongs to manufacturer InMode Ltd., Israel.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>\u2019Radio-Frequency assisted liposuction systems\u2019 based on the falsified copy of certificate no. 2120853CE01<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-08-08-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>08.08.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>Hyperbaric Oxygen Treatment Systems (Hyperbaric Oxygen Chamber) \u2013 Multiplace Omega, Multiplace Cylindirical, Multiplace Quadro, Monoplace<\/strong> accompanied by falsified CE certificate no. 2195-MED-401431701 which would have been issued by Notified Body Szutest Uygunluk De\u011ferlendirme A.\u015e., Turkey (2195) on 2014-11-13, revised on 2019-11-12 and valid until 2025-05-26 for manufacturer <strong>Oxycare Prefabrik Mobil \u00c7\u00f6z\u00fcmler Sanayi \u0130thalat \u0130hracat Ticaret Limited \u015eirketi, Turkey<\/strong>.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Hyperbaric Oxygen Treatment Systems (Hyperbaric Oxygen Chamber) \u2013 Multiplace Omega, Multiplace Cylindirical, Multiplace Quadro, Monoplace, based on the falsified certificate<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-21-06-2024-2\/\">Important notification<\/a><div class=\"content\"><p><strong>21.06.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>\u2019UNIQA Dental Implants- Systems: Dental Implants, Dental Abutments and Superstructures\u2019 manufactured by UNIQA Dental Ltd., Israel<\/strong>, for which they have come into possession of the falsified copy of the EC certificate of conformity no. D1437000001 which would have been issued by Notified Body mdc medical device certification GmbH, Germany (0483) on 2023-02-18, valid until 2028-02-18 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>\u2019UNIQA Dental Implants- Systems: Dental Implants, Dental Abutments and Superstructures\u2019 from manufacturer UNIQA Dental Ltd., Israel, based on the falsified copy of the CE certificate<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\n<strong>The valid certificate, held by this manufacturer, had the same number, was issued by Notified Body mdc medical device certification GmbH, Germany (0483) on 2019-02-18 and was valid until 2023-02-18 for the same product categories.<\/strong><br \/>\nFor personal verification, we recommend that interested parties consult the information on the website of Notified Body mdc medical device certification GmbH, Germany (0483) by accessing this link:<br \/>\n<a href=\"https:\/\/www.mdc-ce.de\/downloads\/mdc-documents\/lists-of-certificates.html?L=\" target=\"_blank\">https:\/\/www.mdc-ce.de\/downloads\/mdc-documents\/lists-of-certificates.html?L=<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-21-06-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>21.06.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>\u2019Diagnostic Ultrasound Systems, Wireless Probe Type Ultrasound Scanner\u2019 manufactured by Sonostar Technologies Co., Ltd., China<\/strong>, for which they have come into possession of the falsified copy of the EC certificate of conformity no. G1 095448 0004 Rev. 00 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2019-08-30.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>\u2019Diagnostic Ultrasound Systems, Wireless Probe Type Ultrasound Scanner\u2019 from manufacturer Sonostar Technologies Co., Ltd., China, based on the falsified copy of the CE certificate<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\n<strong>The valid certificate, held by this manufacturer, had the same number, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), on 2017-06-22, supplemented on 2018-08-30, was valid until 2022-06-21 and covered the same product categories.<\/strong><br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-12-06-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>12.06.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>\u2019Diagnostic Ultrasound Systems, Wireless Probe Type Ultrasound Scanner\u2019 manufactured by Sonostar Technologies Co., Ltd., China<\/strong>, for which they have come into possession of the falsified copy of the EC certificate of conformity no. G1 095448 0004 Rev. 00 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2018-08-30.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>\u2019Diagnostic Ultrasound Systems, Wireless Probe Type Ultrasound Scanner\u2019 from manufacturer Sonostar Technologies Co., Ltd., China, based on the falsified copy of the CE certificate<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\n<strong>The valid certificate, held by this manufacturer, had the same number, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), on 2017-06-22, supplemented on 2018-08-30, was valid until 2022-06-21 and covered the same product categories.<\/strong><br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-30-05-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>30.05.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>\u2019Self tests \u2013 Rapid tests for self testing of infectious diseases : Candida Albicans (Yeast) Antigen Rapid Test Kit, Gardnerella Vaginalis Antigen Rapid Test Kit, Trichomonas Vaginalis Antigen Rapid Test Kit, Trichomonas V.\/ C.albs(yeast) \/ Gardnerella V.Ag Test Triple(3 in 1) STD panel Rapid Test Kit, Candida Albs (Yeast) \/ Gardnerella Vaginalis Antigen Combo (2\/1) Rapid Test Kit, Fecal Occult Blood (FOB) Rapid Test, FSH Menopasure Rapid Test Kit for Home Usage, Hcg Pregnancy Rapid Test Kits for Home Usage,H. Pylori Antigen Detection, LH Ovulation Rapid Test Kts for Home Usage, Trichomoans V.\/ C.albs (yeast) Ag Test Combo (2 in 1) STI panel Rapid Test Kit, Standard Sexual Health Self Rapid Urine Test (7 in 1)\u2019 manufactured by Jei Daniel (JD) Biotech Corp., China<\/strong>, for which they have come into possession of the falsified copy of the EC certificate of conformity no. V1 063963 0008 Rev. 00 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2020-08-16, valid from 2020-09-04 to 2025-09-03 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>\u2019Self tests \u2013 Rapid tests for self testing of infectious diseases : Candida Albicans (Yeast) Antigen Rapid Test Kit, Gardnerella Vaginalis Antigen Rapid Test Kit, Trichomonas Vaginalis Antigen Rapid Test Kit, Trichomonas V.\/ C.albs(yeast) \/ Gardnerella V.Ag Test Triple(3 in 1) STD panel Rapid Test Kit, Candida Albs (Yeast) \/ Gardnerella Vaginalis Antigen Combo (2\/1) Rapid Test Kit, Fecal Occult Blood (FOB) Rapid Test, FSH Menopasure Rapid Test Kit for Home Usage, Hcg Pregnancy Rapid Test Kits for Home Usage,H. Pylori Antigen Detection, LH Ovulation Rapid Test Kts for Home Usage, Trichomoans V.\/ C.albs (yeast) Ag Test Combo (2 in 1) STI panel Rapid Test Kit, Standard Sexual Health Self Rapid Urine Test (7 in 1)\u2019 from manufacturer Jei Daniel (JD) Biotech Corp., China, based on the falsified copy of the CE certificate<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\n<strong>The valid certificate, held by this manufacturer, has the same number, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), valid from 2018-09-04 to 2023-09-03 and covers only the following product categories: Self tests \u2013 Rapid tests for self-testing of infectious diseases : Candida Albicans (Yeast) Antigen Rapid Test Kit, Gardnerella Vaginalis Antigen Rapid Test Kit, Trichomonas Vaginalis Antigen Rapid Test Kit, Trichomonas V.\/ C.albs(yeast) \/ Gardnerella V.Ag Test Triple(3 in 1) STD panel Rapid Test Kit, Candida Albs (Yeast) \/ Gardnerella Vaginalis Antigen Combo (2\/1) Rapid Test Kit, Fecal Occult Blood (FOB) Rapid Test, FSH Menopasure Rapid Test Kit for Home Usage, Hcg Pregnancy Rapid Test Kits for Home Usage,H. Pylori Antigen Detection, LH Ovulation Rapid Test Kts for Home Usage, Trichomoans V.\/ C.albs (yeast) Ag Test Combo (2 in 1) STI panel Rapid Test Kit, Trichomonas V \/Gardnerella V Antigen Combo (2\/1) Rapid Test Kit.<\/strong><br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-28-05-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>28.05.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>\u2019Patient Monitoring Devices, Vital Signs Monitor, Center Monitoring System, Telemetry Monitoring System, Ambulatory Blood Pressure Monitor, Pulse Oximeter, Temperature Probe, SPO2 Sensors, External Defibrillator Paddles, Anaesthetic Vaporizer, Defibrillator\/Monitor, Electrocardiograph, Wearable ECG Recorder, Anesthesia Machine, Ventilator, Ultrasonic Diagnostic Equipment, Ultrasonic Transducer, Digital Radiography System, Radiography System, Magnetic Resonance Imaging System\u2019<\/strong> accompanied by the falsified copy of CE certificate of conformity no. G1 18 03 44751 113, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2018-07-09, valid until 2025-02-21.<br \/>\n<strong>The valid CE Certificate of Conformity with No. G1 18 03 44751 113, issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2018-07-09, valid until 2020-02-21, for the same product categories, belonged to manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>\u2019Patient Monitoring Devices, Vital Signs Monitor, Center Monitoring System, Telemetry Monitoring System, Ambulatory Blood Pressure Monitor, Pulse Oximeter, Temperature Probe, SPO2 Sensors, External Defibrillator Paddles, Anaesthetic Vaporizer, Defibrillator\/Monitor, Electrocardiograph, Wearable ECG Recorder, Anesthesia Machine, Ventilator, Ultrasonic Diagnostic Equipment, Ultrasonic Transducer, Digital Radiography System, Radiography System, Magnetic Resonance Imaging System\u2019 based on the falsified copy of certificate no. G1 18 03 44751 113<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-09-05-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>09.05.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>\u2019Intense Pulsed Light for medical use + Diode Laser Equipment for medical use, CO2 Fractional Laser Equipment for medical use\u2019 manufactured by Beijing Globalipl Development Co., Ltd., China<\/strong>, for which they have come into possession of the falsified copy of the CE certificate of conformity no. G1 002325 0002 Rev. 01, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2023-10-28, valid until 2027-12-31.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>\u2019Intense Pulsed Light for medical use + Diode Laser Equipment for medical use, CO2 Fractional Laser Equipment for medical use\u2019 from manufacturer Beijing Globalipl Development Co., Ltd., China, based on the falsified copy of the CE certificate<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\n<strong>The valid certificate, held by this manufacturer, has the same number and was initially issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2018-12-07, valid until 2023-10-27, for the same product categories.<\/strong><br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-08-05-2024-2\/\">Important notification<\/a><div class=\"content\"><p><strong>08.05.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>\u2019Dental Unit\u2019 manufactured by Foshan Hongke Medical Instrument Factory, China,<\/strong> for which they have come into possession of the falsified copy of the EC certificate of conformity no. G2 17 02 83445 004, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2019-07-10, valid until 2025-07-09 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>\u2019Dental Unit\u2019 from manufacturer Foshan Hongke Medical Instrument Factory., China, based on the falsified copy of the CE certificate<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\n<strong>The valid certificate, held by this manufacturer, has the same number, was issued for the same product categories by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2017-07-10 and was withdrawn on 2022-05-16 upon manufacturer\u2019s request.<\/strong><br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the Database of falsified certificates at the following link<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-08-05-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>08.05.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>Autoclave, Hydrogen peroxide plasma sterilizer, Ethylene oxide sterilizer, Low temperature steam formaldehyde sterilizer, Washer-disinfector manufactured by Hongshun Medical Instrument Co., Ltd., China<\/strong> for which they have come into possession of the falsified CE certificate of conformity no. G1 041505 0125 Rev. 00 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2024-01-17, valid until 2029-01-16, for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Autoclave, Hydrogen peroxide plasma sterilizer, Ethylene oxide sterilizer, Low temperature steam formaldehyde sterilizer, Washer-disinfector from manufacturer Hongshun Medical Instrument Co., Ltd., China, based on the falsified certificate<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the Database of falsified certificates at the following link<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-30-01-2024-3\/\">Important notification<\/a><div class=\"content\"><p><strong>30.01.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>\u2019Blood Collection Needles for Single Use, Disposable Blood Lancets, Disposable Safety Lancets\u2019 manufactured by Liuyang Sanli Medical Technology Development Co.,Ltd., China<\/strong>, for which they have come into possession of the falsified copy of the EC certificate of conformity no. G2 099529 0002 Rev. 00 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2019-07-31, valid until 2024-07-30 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>\u2019Blood Collection Needles for Single Use, Disposable Blood Lancets, Disposable Safety Lancets\u2019 from manufacturer Liuyang Sanli Medical Technology Development Co.,Ltd., China, based on the falsified certificate<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\n<strong>The valid certificate held by this manufacturer has the same number and was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), on 31.07.2018, valid until 30.07.2023 for the same product categories.<\/strong><br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-30-01-2024-2\/\">Important notification<\/a><div class=\"content\"><p><strong>30.01.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>Pulse oximeters, Vital signs monitors, Patient monitors manufactured by Zhuhai Topwinner Meditech Limited., China<\/strong>, for which they have come into possession of the falsified CE certificate of conformity no. 7003GB410190920 which would have been issued by Notified Body DNV MEDCERT GmbH, Germany (0482) on 2019-09-20, valid until 2024-11-06 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Pulse oximeters, Vital signs monitors, Patient monitors from manufacturer Zhuhai Topwinner Meditech Limited., China, based on the falsified certificate<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-30-01-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>30.01.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market in vitro diagnostic medical devices of type: <strong>\u2019Fin\u0435\u0441\u0430r\u0435TM Fully-Automatic FlA Analyzer\u2019 manufactured by Guangzhou Wondfo Biotech Co., Ltd., China<\/strong>, for which they have come into possession of the falsified copy of the EC certificate of conformity no. V74 058008 0034 Rev. 00 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2021-08-12, valid until 2024-04-20 for this manufacturer.<br \/>\nIf you have come into possession of such in vitro diagnostic medical devices or are aware of distributors who sell: <strong>\u2019Fin\u0435\u0441\u0430r\u0435TM Fully-Automatic FlA Analyzer\u2019 from manufacturer Guangzhou Wondfo Biotech Co., Ltd., China, on Romanian territory, based on the falsified certificate<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\n<strong>The valid certificate held by this manufacturer has the same number and was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), on 2021-08-12 and is valid until 2026-08-11 for the following product categories:<br \/>\nFinecareTM CRP Test W201P0010<br \/>\nFinecareTM CRP Test W201P0011<br \/>\nFinecareTM HbA1c Test W207-C7PM<\/strong><br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-26-01-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>26.01.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>X Ray and accessories; Ultrasound; Laboratory; Operation -room equipment; Dental; Infants Care; Sterilization equipment; Morque supplies; Veterinary equipment manufactured by Guanzhou Yueshen Medical Equipment Co., Ltd., China<\/strong>, for which they have come into possession of the falsified CE certificate of conformity no. 7003GB410160415 which would have been issued by Notified Body DNV MEDCERT GmbH, Germany (0482) on 2020-04-15, valid until 2023-11-06 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>X Ray and accessories; Ultrasound; Laboratory; Operation -room equipment; Dental; Infants Care; Sterilization equipment; Morque supplies; Veterinary equipment from manufacturer Guanzhou Yueshen Medical Equipment Co., Ltd., China, based on the falsified certificate<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-23-01-2024\/\">Important notification<\/a><div class=\"content\"><p><strong>23.01.2024<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type <strong>\u2019dental products, otoplastic products \u2013 cavity cleaning liquid; resins for the fabrication of otoplastics; dental cements; materials for the manufacturing of temporary crowns and bridges; one-component material, light curing; composite-based fissure sealant, light curing; permanently soft denture relining materials; epithesis material; protective lacquer for root dentine; dental moldings\u2019, manufactured by DETAX GmbH &#038; Co. KG, Germany<\/strong>, if they have come into possession of the falsified copy of the CE certificate of conformity no. D1002700048 which would have been issued by Notified Body mdc medical device certification GmbH, Germany (0483) on 25.04.2023 valid until 20.04.2026 for this manufacturer.<br \/>\n<strong>The valid certificate issued by Notified Body mdc medical device certification GmbH, Germany (0483) for manufacturer DETAX GmbH &#038; Co. KG, Germany has the same identification number and different dates of issue and expiry, 05.05.2021 and 26.05.2024.<\/strong><br \/>\nIf you have come into possession of such medical devices,  for which you were shown the falsified copy of the CE certificate of conformity no. D1002700048 , do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information  on the website of Notified Body mdc medical device certification GmbH, Germany (0483) by accessing this link:<br \/>\n<a href=\"https:\/\/www.mdc-ce.de\/downloads\/mdc-documents\/lists-of-certificates.html?L=\" target=\"_blank\">https:\/\/www.mdc-ce.de\/downloads\/mdc-documents\/lists-of-certificates.html?L=<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-18-12-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>18.12.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>\u2019Latex Gloves, Vinyl Gloves, Nitrile Gloves (For single use)\u2019 manufactured by Taiyu Gloves CO., Limited, China<\/strong>, if they have come into possession of the falsified CE certificate of conformity no. G2S 08 09 64733 008 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2022-11-29, valid until 2025-11-28 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>\u2019Latex Gloves, Vinyl Gloves, Nitrile Gloves(For single use)\u2019 from manufacturer Taiyu Gloves CO., Limited, China<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-14-12-2023-2\/\">Important notification<\/a><div class=\"content\"><p><strong>14.12.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>\u2019Disposable Latex Surgical Gloves, Disposable Latex Examination Gloves\u2019 manufactured by Pidegree Industrial Co.,Limited., China<\/strong>, if they have come into possession of the falsified copy of the EC certificate of conformity no. G2 074980 0012 Rev. 01 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2020-03-04, valid until 2024-05-26 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>\u2019Disposable Latex Surgical Gloves\u2019, \u2018Disposable Latex Examination Gloves\u2019 from manufacturer Pidegree Industrial Co., Limited., China<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\n<strong>The valid certificate with the same identification data, namely number, date of issue and expiry and belonging to product category \u2018Disposable Latex Surgical Gloves\u2019, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), for manufacturer Tianchang Hengsheng Medical Devices Co.,Ltd., China.<\/strong><br \/>\nFor personal verification, we recommend that interested parties consult the information on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-14-12-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>14.12.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>\u2019Dental Suction Systems\u2019 manufactured by Suzhou Junwei Medical Equipment Co., Ltd., China<\/strong>, if they have come into possession of the falsified EC certificate of conformity no. G2 18 04 82113 008 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2023-05-25, valid until 2025-05-24, for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Dental Suction Systems from manufacturer Suzhou Junwei Medical Equipment Co., Ltd., China, based on the falsified certificate<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\n<strong>Atragem aten\u021bia p\u0103r\u021bilor interesate c\u0103, potrivit informa\u021biilor intrate \u00een posesia ANMDMR, \u00een afara certificatului falsificat mai sus men\u021bionat, pentru acest produc\u0103tor mai exist\u0103 pe pia\u021ba UE \u0219i certificatul falsificat nr. Q8 082551 0003 Rev. 01 which would have been issued by Certifying Body T\u00dcV S\u00dcD Product Service GmbH, Germany on 2022-04-25, valid until 2025-04-24 in accordance with the requirements of standard EN ISO 13485:2016 \u2013 Quality management systems. Requirements for regulatory purposes for Design and Development, Production and Distribution of Medical Oil Free Air Compressors, Dental Suction Systems.<\/strong><br \/>\nFor personal verification, we recommend that interested parties consult the information on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-13-12-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>13.12.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>\u2019Medical Natural Rubber Latex Examination Glove\u2019, \u2018Examination Synthetic Rubber Latex Examination Glove\u2019, \u2018Disposable Synthetic Rubber Latex Surgical Glove\u2019, manufactured by Ace Glove(M) Sdn. Bhd., Malaysia<\/strong>, if they have come into possession of the falsified copy of certificate no. Q5 055729 0012 Rev.01 which would have been issued by Certifying Body T\u00dcV S\u00dcD Product Service GmbH, Germany, in accordance with the requirements of standard EN ISO 13485:2016 \u2013 Quality management systems, QMS regulatory requirements, on 2023-05-01, valid until 2026-04-30, for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Medical Natural Rubber Latex Examination Glove, Examination Synthetic Rubber Latex Examination Glove, Disposable Synthetic Rubber Latex Surgical Glove from manufacturer Ace Glove(M) Sdn. Bhd., Malaysia<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\n<strong>The valid certificate with the same identification data, namely number, issue and expiry date was issued by Certifying Body T\u00dcV S\u00dcD Product Service GmbH, Germany for manufacturer Top Glove Sdn. Bhd. Malaysia, for:<br \/>\n\u2013 Design and Development, Manufacture and Distribution of:<br \/>\n1. Non-Sterile Natural Rubber Latex Examination Glove<br \/>\n2. Non-Sterile Synthetic Rubber Latex Examination Glove<br \/>\n\u2013 Manufacture and Distribution of:<br \/>\n1. Sterile Synthetic Rubber Latex Surgical Glove.<\/strong><br \/>\nFor personal verification, we recommend that interested parties consult the information on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\nhttps:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<br \/>\nDatabase of falsified certificates:<br \/>\nhttps:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-08-11-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>08.11.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: Spacer for aerosol manufactured by Ningbo Foyomed Medical Instruments Co., Ltd., China, if they have come into possession of the falsified copy of CE certificate of conformity no. G2 093011 0006 Rev.01 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), on 2019-11-26, valid until 2024-05-26 for this manufacturer, copy which includes this medical device as well.<br \/>\n<strong>The valid certificate, issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) for manufacturer Ningbo Foyomed Medical Instruments Co., Ltd., China has the same identification data, namely number, issue and expiry date and covers only the following product categories: Sterile Nonactive Medical Devices and Active Medical Devices \u2013 Endotracheal Tube, Reinforced Endotracheal Tube, Latex Foley Catheter, Urethral Catheters(PVC), Nelaton Catheters(latex), Laryngeal Mask Airways, Tracheostomy Masks, Oxygen Masks, Nebulizers Masks, Venturi Masks, Oxygen Masks With Reservoir Bag, Connecting Tubes With Yankauer Handle, Oxygen Connection Tubings, Nasal Oxygen Cannula, Safety Syringes, Auto Disable Syringes, Disposable Syringes, Disposable Hypodermic Needles, Safety Disable Syringe, Sterile Infusion Sets for Single Use, Sterile Transfusion Sets for Single Use, Sterile Scalp Vein Type Needles for Single Use, Three-way Stopcocks(with Extension Tube), Heparin Caps, I.V. Cannula for Single Use, Insulin Needles for Single Use, Disposable Scalpel With Plastic Handle, Blood Lancet, Sterile Surgical Blade, Gauze Balls, Non-woven Balls(with X-ray), Lap Sponges, Oropharyngeal Airway, Resuscitation Mask, Silicone\/SEBS\/PVC Manual Resuscitators, Wound Drainage Reservoir, Sterile Latex Surgical Gloves, Digital Thermometers, Digital Blood Pressure Monitors, Electronic Sphygmomanometers, Disposable Irrigating and Feeding Syringes, Disposable Cervical Brushes.<\/strong><br \/>\nWe hereby draw the attention of interested parties that, according to the information held by the NAMMDR, in addition to the falsified copy of the above-mentioned certificate, for this manufacturer there is also a forged copy of certificate no. Q6 093011 0010 Rev. 00 which would have been issued by Certifying Body T\u00dcV S\u00dcD Product Service GmbH, Germany on 2022-07-06 valid until 2025-01-26 in accordance with the requirements of standard EN ISO 13485:2016 \u2013 Quality management systems. Requirements for regulatory purposes for <strong>Production and Distribution of Medical Devices \u2013 Endotracheal Tube, Reinforced Endotracheal Tube, Latex Foley Catheter, Urethral Catheters (PVC), Nelaton Catheters (latex), Sterile Feeding Tubes, Disposable Rectal Tubes, Sterile Suction Catheters, Disposable Stomach Tubes, Disposable Mucus Extractors, Disposable Umbilical Cord Clamps, Disposable I.D. Bracelets, Laryngeal Masks Airways, Tracheostomy Masks, Oxygen Masks, Nebulizers Masks, Venturi Masks, Oxygen Masks with Reservoir Bag, Connecting Tubes with Yankauer Handle, Oxygen Connection Tubings, Nasal Oxygen Cannula, Safety Syringes, Auto Disable Syringes, Disposable Syringe, Disposable Hypodermic Needles, Safety Disable Syringes, Sterile Infusion Sets for Single Use, Sterile Transfusion Sets for Single Use, Sterile Scalp Vein Type Needles for Single Use, Disposable Irrigating and Feeding Syringes, Three-way Stopcocks (with Extension Tube), Heparin Caps, I.V. Cannula for Single Use, Insulin Needles for Single Use, Disposable Scalpel with Plastic Handle, Blood Lancet, Sterile Surgical Blade, Gauze Rolls, Gauze Bandages, Gauze Sponges, Alcohol Pad, CPR Mask, Gauze Balls, Non-woven Balls (with X-ray), Lap Sponges, Cotton Tipped Applicators, Absorbent Cotton Balls, Medical Dressing Kits, Dressing Eye Pads, Absorbent Cotton Wools, Surgical Brushes, Oropharyngeal Airway, Resuscitation Mask, Silicone\/SEBS\/PVC Manual Resuscitators, Wound Drainage Reservoir, Urine Bag, Swab, Disposable Cervical Brushes, Sterile Examination Gloves, Sterile Latex Surgical Gloves, Surgical Gowns, Digital Thermometers, Digital Blood Pressure Monitors, Electronic Sphygmomanometers, Medical Bandages, Adhesive Dressing Series, Non-woven Gowns, Non-woven Face Mask, Non-woven Caps, Non-woven Shoe Cover, PE Aprons, Stethoscope, ECG Electrode, TENS Electrode, Wheel Chairs, Walking Aids, Operating Tables, Operating Lamps, Oxygen Concentrators, Vaginal Speculum, Disposable Surgical Drape, Adult Diaper, Silicone Condom Catheter, Wooden Tongue Depressors, Frozen Ice Pack, Mattresses, Ear\/Ulcer Syringe, Single-use Medical Packing for Sterilized Medical Devices, Spacer for aerosol<\/strong>.<br \/>\nIf you have come into possession of such medical devices of type Spacer for aerosol for which you were shown a falsified copy of the Certificate of Conformity no. G2 093011 0006 Rev.01 or of certificate no. Q6 093011 0010 Rev. 00 , do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-30-10-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>30.10.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>Blood glucose monitoring systems (B12, B12 LAEN, B13, B14, B15, B16, B17, B18, B19) manufactured by Prolinx GmbH, Germany<\/strong>, if they have come into possession of the falsified CE certificate of conformity no. N50569-15-8 which would have been issued by Notified Body mdc medical device certification GmbH, Germany (0483), on 2021-08-18, valid until 2024-07-02 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Blood glucose monitoring systems (B12, B12 LAEN, B13, B14, B15, B16, B17, B18, B19) from manufacturer Prolinx GmbH, Germany<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information on the website of Notified Body mdc medical device certification GmbH, Germany (0483), by accessing the link below:<br \/>\n<a href=\"https:\/\/www.mdc-ce.de\/downloads\/mdc-documents\/lists-of-certificates.html\" target=\"_blank\">https:\/\/www.mdc-ce.de\/downloads\/mdc-documents\/lists-of-certificates.html<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-02-10-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>02.10.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market <strong>Patient Monitoring Devices, Defibrillator\/Monitor, Electrocardiograph, Anesthesia Machine, Ultrasonic Diagnostic Equipment, Digital radiography System manufactured by PT. Mindray Medical Indonesia, Indonesia<\/strong>, if they have come into possession of the falsified CE certificate of conformity no. G1 10 08 44751 054 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), on 2020-09-17, valid until 2025-02-21 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Patient Monitoring Devices, Defibrillator\/Monitor, Electrocardiograph, Anesthesia Machine, Ultrasonic Diagnostic Equipment, Digital radiography System from manufacturer PT. Mindray Medical Indonesia, Indonesia<\/strong>, do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nWe would like to warn interested parties that, according to the information held by the NAMMDR, in addition to the above-mentioned falsified certificate, the following falsified certificates exist on the EU market as well, for this manufacturer:<br \/>\n\u2013 Certificate no. S 951 11 4754 which would have been issued by Notified Body TUV SUD AMERICA INC. on 4 Octombrie 2022, valid until 31 August 2025, in accordance with the requirements of ISO 9001:2008 quality management system for <strong>Design and Development, Production and Distribution of Medical Electronic Equipment (including Patient Monitor and Accessories, Defibrillator\/Monitor and Accessories, Electro-Cardiograph, Anesthesia Machine and Accessories, Ventilator, Ultrasonic Diagnostic Equipment and Accessories, Digital Radiography System, Magnetic Resonance Imaging System, Hematology Analyzer, Clinical Chemistry Analyzer and Microplate Reader, Microplate Washer for invitro Diagnostic use), Reagents for Hematology Analyzer, Reagents for Clinical Chemistry Analyzer<\/strong><br \/>\n\u2013 Certificate no. Q1N 11 05 44751 057 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), on 01.09.2022, valid until 31.08.2025, in accordance with the requirements of standard EN ISO 13485:2016 for <strong>Design and Development, Production and Distribution of Medical Electronic Equipment (including Patient Monitor and Accessories, Defibrillator\/Monitor and Accessories, Electrocardiograph, Anesthesia Machine, Ventilator, Ultrasonic Diagnostic Equipment and Accessories, Digital Radiography System, Hematology Analyzer, Clinical Chemistry Analyzer and Microplate Reader, Microplate Washer for in-vitro diagnostic use), Reagents for Hematology Analyzer, Reagents for Clinical Chemistry Analyzer<\/strong><br \/>\nFor personal verification, we recommend that interested parties consult the information on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nBaza de date cu certificate:<br \/>\nhttps:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<br \/>\nDatabase of falsified certificates:<br \/>\nhttps:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-27-09-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>27.09.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type <strong>\u2019One Step Rapid Diagnostic Step \u2013 One Step HBsAg Test (Strip B11-11, Cassette B11-20), One Step HCV Test (Strip B20-11, Cassette B20-20), One Step HIV 1+2Test (Strip C10-11, Cassette C10-20)\u2019<\/strong>, if they have come into possession of a falsified copy of the EC Certificate of Conformity no. 2022-IVD\/QS-007 for these medical devices, which would have been issued by Notified Body 3EC International a.s., Slovakia (2265) on 25 Mai 2022 valid until 26 Mai 2025.<br \/>\n<strong>The valid certificate with the same identification data, namely number, product categories, issue and expiry date One Step Rapid Diagnostic Test \u2013 CoretestsOne Step HBsAg Test (Strip B11-11, Cassette B11-20), CoretestsOne Step HCV Test (Strip B20-11, Cassette B20-20), CoretestsOne Step HIV 1+2 Test (Strip C10-11, Cassette C10-20) was issued by Notified Body 3EC International a.s., Slovakia (2265) for manufacturer Core Technology Co., Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices, for which you were shown the falsified copy of the CE certificate of conformity no. 2022-IVD\/QS-007, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult this information posted on the website of Notified Body 3EC International a.s., Slovakia (2265), by accessing the link below:<br \/>\nDatabase of falsified certificates: <a href=\"https:\/\/www.3ec.sk\/en\/services\/falsificates\/\" target=\"_blank\">https:\/\/www.3ec.sk\/en\/services\/falsificates\/<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-25-09-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>25.09.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Diode laser hair removal machine for medical use manufactured by Beijing Lead Beauty S &#038; T Co. Ltd., People\u2019s Republic of China<\/strong>, if they have come into possession of the falsified copy of CE certificate of conformity no. G1 005392 0002 Rev. 01 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), on 2020-02-17, valid until 2024-05-26 for this manufacturer.<br \/>\n<strong>The valid certificate, with the same identification data, namely number, issuance and expiry date and medical devices categories \u2018Diode laser hair removal machine for medical use, Intense pulsed light therapy device (IPL) for medical use\u2019, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), for manufacturer Beijing Nubway S &#038; T Co., Ltd., People\u2019s Republic of China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Diode laser hair removal machine for medical use from manufacturer Beijing Lead Beauty S &#038; T Co. Ltd., People\u2019s Republic of China, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nBaza de date cu certificate:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-07-08-2023-3\/\">Important notification<\/a><div class=\"content\"><p><strong>07.08.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Hip Implants, Bipolar Head manufactured by OHST Medizintechnik AG, Germany<\/strong>, if they have come into possession of the Falsified CE design examination certificate no. 13434GB411150818, which would have been issued by Notified Body MEDCERT GmbH , Germany (0482), on 2020-08-18, valid until 2030-12-22 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Hip Implants, Bipolar Head from manufacturer OHST Medizintechnik AG, Germany<\/strong>, based on the falsified certificate previously mentioned, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-07-08-2023-2\/\">Important notification<\/a><div class=\"content\"><p><strong>07.08.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Hip Implants, Bipolar Head manufactured by OHST Medizintechnik AG, Germany<\/strong>, if they have come into possession of the Falsified CE design examination certificate no. 13434GB411150818, which would have been issued by Notified Body MEDCERT GmbH , Germany (0482), on 2020-08-18, valid until 2030-12-22 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Hip Implants, Bipolar Head from manufacturer OHST Medizintechnik AG, Germany<\/strong>, based on the falsified certificate previously mentioned, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-07-08-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>07.08.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Oral Dispenser \u2013 2ml, 3ml, 5ml, 6ml, 10ml, 12ml, 20ml, Rubber Dropper Assembly, Glass Dropper Assembly, Measuring Cups, Measuring Spoons, Pilfer Proof Caps, Child Resistance Caps (CRC), Flip Top Caps, Tablet Bottles, Silicon Rubber Teats, Eye Drop Bottles, Dry Syrup Bottles, Crew Caps, Adopter, Plastic Plug, Piles Applicators, PCO Caps, Baby Droppers Set, Tablet Applicators, Gel Applicators, Oral Dispenser (0.3ml, 0.5ml, 1ml) manufactured by Neelkanth Polymer Industries, India<\/strong>, if they have come into possession of the falsified CE certificate of conformity no. DGM 930 which would have been issued by Notified Body Presafe Denmark A\/S, Denmark (0483), on 2020-10-07, valid until 2025-10-06 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Oral Dispenser \u2013 2ml, 3ml, 5ml, 6ml, 10ml, 12ml, 20ml, Rubber Dropper Assembly, Glass Dropper Assembly, Measuring Cups, Measuring Spoons, Pilfer Proof Caps, Child Resistance Caps (CRC), Flip Top Caps, Tablet Bottles, Silicon Rubber Teats, Eye Drop Bottles, Dry Syrup Bottles, Crew Caps, Adopter, Plastic Plug, Piles Applicators, PCO Caps, Baby Droppers Set, Tablet Applicators, Gel Applicators, Oral Dispenser(0.3ml, 0.5ml, 1ml) from manufacturer Neelkanth Polymer Industries, India<\/strong>, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-21-07-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>21.07.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all interested parties (importers, distributors, users \u2013 health units and patients)<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Sodium hialuronate injection, Cross-Linked Sodium Hyaluronate Injection by Genu Vida, various strengths, manufactured by Heil Pharma, India, marked on the packaging only with the CE marking, if they have come into possession of certificate no. BQC23HP44IN issued by BQS Certification Services, Brazil on 14-04-2023, valid until 13-04-2026, entity that does not have Notified Body status in Brussels according to Directive 93\/42\/EEC or Regulation (EU) 2017\/745 on medical devices.<br \/>\nThe introduction of this type of medical device on the EU market (class III) can only be done with the involvement of a Notified Body in Brussels according to Directive 93\/42\/EEC or Regulation (EU) 2017\/745 on medical devices. In this case, devices of the type mentioned above must bear the CE marking accompanied by the identification number of the Notified Body in Brussels, involved in assessing the conformity of those devices with general safety and performance requirements applicable to the risk class to which they belong.<br \/>\nWe hereby warn state and private healthcare facilities as well as patients not to use intraarticular medical devices \u2018Sodium hyaluronate injection, Cross-Linked Sodium Hyaluronate Injection brand Genu Vida\u2019, various strengths, manufactured by Heil Pharma, India, marked on the packaging only with the CE marking<\/strong> if they have come into possession of them and to notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website, if they are aware of distributors who have marketed these medical devices on the Romanian territory.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-07-06-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>07.06.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Blood pressure monitors, thermometers, suction, nebulizers, digital color doppler, hearing aids manufactured by Prolinx GmbH(ALPHA), Germany<\/strong>, if they have come into possession of the falsified CE certificate of conformity no. N50569-14-7 which would have been issued by Notified Body mdc medical device certification GmbH, Germany (0483), on 2019-12-08, valid until 2023-07-02 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Blood pressure monitors, thermometers, suction, nebulizers, digital color doppler, hearing aids from manufacturer Prolinx GmbH(ALPHA), Germany<\/strong>, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body mdc medical device certification GmbH, Germany (0483), by accessing the link below:<br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.mdc-ce.de\/fileadmin\/user_upload\/Downloads\/mdc-Dokumente\/Kundenlisten\/Gef%C3%A4lschte_Zertifikate_List_of_forged_certificates_2023-06-01.pdf\" target=\"_blank\">https:\/\/www.mdc-ce.de\/fileadmin\/user_upload\/Downloads\/mdc-Dokumente\/Kundenlisten\/Gef%C3%A4lschte_Zertifikate_List_of_forged_certificates_2023-06-01.pdf<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-24-04-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>24.04.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Oxidized regenerated cellulose \u2013 Equicel and Equitamp, manufactured by EQUIMEDICAL BV, the Netherlands<\/strong>, if they have come into possession of the falsified CE certificate of conformity no. 11152-2017-CE-IBE-NA-PS Rev. 2.0 and of the falsified CE certificate of conformity no. 11150-2017-CE-IBE-NA-PS Rev. 2.0, which would have been issued by Notified Body DNV GL NEMKO PRESAFE AS, Norway (2460) on 21 April 2021, valid until 21 April 2026 and 20 April 2026, for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Oxidized regenerated cellulose \u2013 Equicel and Equitamp, manufactured by EQUIMEDICAL BV, the Netherlands<\/strong>, based on falsified certificates, do not use them or make them available on the market, return them to the suppliers and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nWe draw the attention of all interested parties to the fact that the latest CE certificates of conformity held by this manufacturer for the medical devices in question, namely CE conformity certificate no. <strong>11152-2017-CE-IBE-NA-PS Rev. 1.0 and CE design examination certificate no. 11150-2017-CE-IBE-NA-PS Rev. 1.0, both valid until 04 April 2023 have been suspended by issuing Notified Body (2460) on 28 May 2019 and subsequently withdrawn by issuing Notified Body (2460) on 11 September 2019<\/strong>. If you have come into possession of these medical devices or are aware of distributors who have marketed these medical devices on Romanian territory based on suspended and withdrawn certificates, stop using them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\n<strong>In addition to the previously mentioned falsified certificates, we hereby draw the attention of interested parties that manufacturer EQUIMEDICAL BV, the Netherlands also holds two other falsified certificates of conformity of the Management System with the requirements of ISO 13485:2003\/NS-EN ISO 13485:2016 for the design, manufacture and wholesale activities of several types of medical devices, among which Oxidized regenerated cellulose. These certificates are: no. 277179-2019-AQ-IBE-NA-PS-Rev1.0 issued on 28 February 2019 and valid until 27 February 2024 and no. 277179-2019-AQ-IBE-NA-PS-Rev 2.0 issued on 21 April 2021 and valid until 20 April 2026 and were apparently issued by the same body, DNV GL NEMKO PRESAFE AS, Norway.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-10-04-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>10.04.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Product for determination of infection markers Model\/(s) In-Vetro Diagnostic Medical Device for Detection of SARS-CoV-2 Antibody (colloidal gold immunochromatography) Model: COVID19 INSTATEST (Self-testing: 1 test per box), manufactured by Beijing Lepu Medical Technology Co. Ltd., China<\/strong>, if they have come into possession of the falsified CE certificate of conformity no. V1.18.02.03496.002 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), on 2020-03-13, valid until 2023-06-27 for this manufacturer.<br \/>\nIf you have come into possession of such in vitro diagnostic medical devices or are aware of distributors who sell on the Romanian territory these types of devices based on the aforementioned falsified certificate, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-31-03-2023-2\/\">Important notification<\/a><div class=\"content\"><p><strong>31.03.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Blood separating kit, manufactured by Glofinn Co., Ltd., Republic of Korea<\/strong>, if they have come into possession of the falsified CE certificate of conformity no. G1.098601.0004.Rev.00 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), on 2022-08-10, valid until 2024-08-10 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Blood separating kit<\/strong> from manufacturer <strong>Glofinn Co., Ltd., Republic of Korea<\/strong>, do not place them on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-31-03-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>31.03.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Infusion Pump, Syringe Pump Infusion Warmer, Patient Warming Machine, manufactured by Jiangsu Sinowise Technology Co., Ltd., People\u2019s Republic of China<\/strong>, if they have come into possession of the falsified copy of the CE certificate of conformity no. G1.104715.0002.Rev.01 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2021-04-23, valid until 2024-05-26 for this manufacturer.<br \/>\n<strong>The valid certificate with the same identification data, namely number, issue and expiry date and medical device categories Infusion Pump and Syringe Pump, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany(0123), for manufacturer Dongguan HEPHO Medical Science Technology Co., LTD., People\u2019s Republic of China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Infusion Pump, Syringe Pump Infusion Warmer, Patient Warming Machine from manufacturer Jiangsu Sinowise Technology Co., Ltd., People\u2019s Republic of China<\/strong>, do not place them on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-30-03-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>30.03.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Infusion Sets for Single Use (with Needle), Sterile Hypodermic Syringes for Single Use (with Needle), Disposable Sterile Needles, manufactured by Wuxi Owgels Medical Instruments Co., LTD., China<\/strong>, if they have come into possession of the falsified copy of the CE certificate of conformity no. G2.072857.0013.Rev.00 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2019-10-11, valid until 2024-05-26 for this manufacturer.<br \/>\n<strong>The valid certificate, with the same identification data, namely number, medical device category, issue and expiry date, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), for manufacturer Changzhou Jiafeng Medical Equipment Co., Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Infusion Sets for Single Use (with Needle), Sterile Hypodermic Syringes for Single Use (with Needle), Disposable Sterile Needles from manufacturer Wuxi Owgels Medical Instruments Co.,LTD., China<\/strong>, do not place them on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nBaza de date cu certificate:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-23-03-2023-5\/\">Important notification<\/a><div class=\"content\"><p><strong>23.03.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Equispon Sterile Haemostatic Absorbable Gelatin Sponges, manufactured by EQUIMEDICAL BV, the Netherlands<\/strong>, if they have come into possession of the falsified copy of the CE certificate of conformity no. 12493-2018-CE-IBE-NA-PS Rev. 1.0 and of the CE certificate of conformity no. 12492-2018-CE-IBE-NA-PS Rev. 1.0, which would have been issued by Notified Body DNV GL PRESAFE AS, Norway (2460) on 21 April 2021, valid until 20 April 2026, for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Equispon Sterile Haemostatic Absorbable Gelatin Sponges, manufactured by EQUIMEDICAL BV, the Netherlands<\/strong> based on the falsified certificates, do not use them or make them available on the market, return them to the suppliers and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nWe would hereby like to draw the attention of all interested parties to the fact that the latest CE certificates of conformity held by this manufacturer for the medical devices in question, namely <strong>EC certificate of conformity no. 12492-2018-CE-IBE-NA-PS and EC certificate of conformity no. 12493-2018-CE-IBE-NA-PS, both valid until 28 Mai 2023, were suspended by the issuing Notified Body (2460) on 28 May 2019 and recalled by the issuing Notified Body (2460) on 11 September 2019<\/strong>. If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory these medical devices based on suspended and recalled certificates, stop using them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-23-03-2023-4\/\">Important notification<\/a><div class=\"content\"><p><strong>23.03.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: Disposables for Anesthesia and Respiration Disposable Anesthesia Needle and Anesthesia Kit, manufactured by YangZhou SUSMED IMPORT&#038;EXPORT CO.,LTD., China, if they have come into possession of the falsified copy of the CE certificate of conformity no. G7.17.04.82107.009 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2018-03-01, valid until 2022-12-11 for this manufacturer.<br \/>\nThe valid certificate, with the same identification data, namely number, medical device category, issue and expiry date, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), for manufacturer Zhejiang Runqiang Medical Instruments Co., Ltd., People\u2019s Republic of China.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Disposables for Anesthesia and Respiration Disposable Anesthesia Needle and Anesthesia Kit from manufacturer YangZhou SUSMED IMPORT&#038;EXPORT CO.,LTD., China, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nBaza de date cu certificate:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-23-03-2023-3\/\">Important notification<\/a><div class=\"content\"><p><strong>23.03.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: Disposable Anesthesia Needle and Anesthesia Kit, manufactured by YangZhou SUSMED IMPORT&#038;EXPORT CO.,LTD., China, if they have come into possession of the falsified copy of the CE certificate of conformity no. G1.17.12.82107.013 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2018-05-07, valid until 2023-05-06 for this manufacturer.<br \/>\nThe valid certificate, with the same identification data, namely number, medical device category, issue and expiry date, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), for manufacturer Zhejiang Runqiang Medical Instruments Co., Ltd., People\u2019s Republic of China.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Disposable Anesthesia Needle and Anesthesia Kit from manufacturer YangZhou SUSMED IMPORT&#038;EXPORT CO.,LTD., China, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nBaza de date cu certificate:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-23-03-2023-2\/\">Important notification<\/a><div class=\"content\"><p><strong>23.03.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices of Romania warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type \u201dSterile Gauze Swabs, Sterile Non-Woven Sponge, Sterile First Aid Dressing Bandage, Surgical Gowns, Surgical Drapes, Sterile Eye Pad, Sterile Hemostasis Adhesive Dressing Series (Sterile Wound Plaster, Liquid Transfusion Plaster and Adhesive Dressing), Sterile Examination Gloves, Rectal Tube, Urine Drainage Bag, Basic Dressing Packs\u201d, if they have come into possession of a falsified copy of the EC certificate of conformity no. G2S.054580.0023.Rev.01, valid from 2019-09-04 to 2024-05-26, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), for any other manufacturer except for Hygeia Medical Co., Ltd., Shanghai, People\u2019s Republic of China.<br \/>\nThe valid certificate, with the same identification data, namely number, medical device category, issue and expiry date, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), for manufacturer Hygeia Medical Co., Ltd., Shanghai, People\u2019s Republic of China.<br \/>\nIf you have come into possession of such medical devices, for which you were shown the falsified copy of the CE certificate of conformity no. G2S.054580.0023.Rev.01, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nBaza de date cu certificate:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-23-03-2023\/\">Important notification<\/a><div class=\"content\"><p><strong>23.03.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices of Romania warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type \u201dSterile Gauze Swab with X-Ray, Sterile Lap Sponge, Sterile Surgical Gloves, Foley Catheter (Latex), Nelaton Catheter, Endotracheal Tubes, Disposable Syringes, Disposable Infusion Sets, Disposable Blood Transfusion Sets, Disposable Scalp Vein Sets, Disposable Hypodermic Needles, Disposable Surgical Blades, Sterile Scalpel with Plastic Handle, Suction Catheter, Feeding Tube, Stomach Tube, Extension Tube\/Connecting Tube\u201d, if they have come into possession of the falsified copy of the CE certificate of conformity no. G2.054580.0019.Rev.01, valid from 2019-09-04 to 2024-05-26, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), for any other manufacturer except for Hygeia Medical Co., Ltd., Shanghai, People\u2019s Republic of China.<br \/>\nThe valid certificate, with the same identification data, namely number, medical device category, issue and expiry date, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), for manufacturer Hygeia Medical Co., Ltd., Shanghai, People\u2019s Republic of China.<br \/>\nIf you have come into possession of such medical devices, for which you were shown the falsified copy of the CE certificate of conformity no. G2.054580.0019.Rev.01, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nBaza de date cu certificate:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-27-12-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>27.12.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Dental Implant System (including Implant Body, Abutment, Central Screw, Cover Screw), manufactured by Foshan Angels Biotechnology CO. LTD., China<\/strong> if they have come into possession of the falsified copy of the CE certificate of conformity no. G1 093823 0004 Rev. 00 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2022-01-13, valid until 2024-03-13.<br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nBaza de date cu certificate:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-12-12-2022-2\/\">Important notification<\/a><div class=\"content\"><p><strong>12.12.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Integral Dental Unit, manufactured by Foshan Nanhai Hager Medical Machinery Co., Ltd., PEOPLE\u2019S REPUBLIC OF CHINA<\/strong> if they have come into possession of the falsified copy of the CE certificate of conformity no. G2 058482 0010 Rev. 00 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2020-07-07, valid until 2025-07-06 for this manufacturer.<br \/>\nThe valid certificate, with the same number and for the same medical device category, issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) belongs to manufacturer <strong>Foshan Anle Medical Apparatus Co., Ltd., People\u2019s Republic of China<\/strong>.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Integral Dental Unit<\/strong> from manufacturer <strong>Foshan Nanhai Hager Medical Machinery Co., Ltd., PEOPLE\u2019S REPUBLIC OF CHINA<\/strong>, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend interested parties to check this information on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-09-11-2022-2\/\">Important notification<\/a><div class=\"content\"><p><strong>09.11.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>A set of silicone devices for gastric restriction- MediStars Intragastric Balloon, manufactured by JSC \u201cMediStars\u201d, Russia<\/strong> if they have come into possession of the falsified copy of the CE certificate of conformity no. 2019-MDD\/QS-033 which would have been issued by Notified Body 3EC International a.s., Slovakia (2265) on 2019-04-26, valid until 2024-04-25.<br \/>\nFor personal verification, we recommend interested parties to check this information on the website of Notified Body 3EC International a.s., Slovakia (2265), by accessing the link below:<br \/>\nDatabase of falsified certificates: <a href=\"https:\/\/www.3ec.sk\/en\/services\/falsificates\/\" target=\"_blank\">https:\/\/www.3ec.sk\/en\/services\/falsificates\/<\/a>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-09-11-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>09.11.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Hyaluronan Soft Tissue Filling Gel \u2013 Manorui Cross Linked \/ Non Cross Linked Hyaluronic Acid, manufactured by Jining Hangxing E-Commerce Co., Ltd., China<\/strong> if they have come into possession of the falsified copy of the EC certificates of conformity no. 2020-MDD\/QS-008 in line with Annex II, Section 4 excluded, of Directive 93\/42\/EEC and no. 2020-MDD\/DE-025 in line with Annex II, Section 4 of Directive 93\/42\/EEC which would have been issued by Notified Body 3EC International a.s., Slovakia (2265) on 2020-11-07, valid until 2025-11-06.<br \/>\nFor personal verification, we recommend interested parties to check this information on the website of Notified Body 3EC International a.s., Slovakia (2265), by accessing the link below:<br \/>\nDatabase of falsified certificates: <a href=\"https:\/\/www.3ec.sk\/en\/services\/falsificates\/\" target=\"_blank\">https:\/\/www.3ec.sk\/en\/services\/falsificates\/<\/a>.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-04-10-2022-2\/\">Important notification<\/a><div class=\"content\"><p><strong>04.10.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Instrumentos quir\u00fargicos (clase lla), sistemas de endoscopia e accesorios, Instrumentos e accesorios para electrobistur\u00edes, C\u00e1nulas traqueales, Implantes para ortopedia, clips para aneurisma (classe III), Insufladores de C02, Trocars desechables esteriles, manufactured by AMNOTEC International Medical GmbH, Germany<\/strong> if they have come into possession of the falsified copy of the CE certificate of conformity no. HT 09 08 55978 331 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2019-03-14, valid until 2022-09-13.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-04-10-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>04.10.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Dental Devices, Components and Consumables \/ types: Lingual Appliances, Self-Ligating Appliances, Ceramic Brackets, Metal Brackets. Digital Orthodontics Buccal Tubes and Bands, Archwire Systems, Bonding Banding Products and Curing Light for Dental Use, manufactured by 3M UNITEK, Germany \u2013 3M UNITEK Orthodontic Products, SUA<\/strong> if they have come into possession of the falsified copy of the CE certificate of conformity no. G1 07 01 50371 003 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 02 June 2015.<br \/>\nFor personal verification, we recommend interested parties to check this information on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the link below:<br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-05-09-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>05.09.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Orthopaedic Implants &#038; Spinal Implants (Sterile \/ Non-Sterile), manufactured by Sharma Ortho System Pvt. Ltd., India<\/strong>, if they have come into possession of the falsified copy of the CE certificate of conformity no. 2017-MDD\/QS-032, which is claimed to have been issued for this manufacturer by Notified Body 3EC International a.s., Slovakia (2265), on 2017-09-24, valid until 2022-09-23.<br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices which do not comply with applicable regulatory requirements, please exercise extra caution, to permanently consult the NAMMDR website for such information and to ensure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-02-08-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>02.08.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market <strong>the types of medical devices manufactured by Divine Medicure Technology, India<\/strong>, which are the subject of the falsified EC Certificate of Conformity no. 245067-2019-CE-IND-NA-PS Rev. 0.0 which would have been issued by Notified Body DNV GL Presafe AS, Norway (2460) on 15 April 2019, valid until 10 December 2023.<br \/>\n<strong>According to information received by the NAMMDR, Notified Body DNV GL Presafe AS, Norway (2460) has not issued any CE Certificate of Conformity for this manufacturer.<br \/>\nTo prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices which do not comply with applicable regulatory requirements, please exercise extra caution, to permanently consult the NAMMDR website for such information and to ensure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-27-05-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>27.05.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type:<br \/>\n\u2013 <strong>Video Laryngoscope, manufactured by KoMaC Co. Ltd., Korea<\/strong>, if they have come into possession of the falsified copy of the CE certificate of conformity no. G1 075408 0030 Rev.03, issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2019-11-21, valid until 2024-05-26.<br \/>\n\u2013 <strong>Bronchoscope, manufactured by KoMaC Co. Ltd., Korea<\/strong>, if they have come into possession of the falsified copy of the CE certificate of conformity no. G2S 073403 0028, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2019-12-31, valid until 2024-12-30.<br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices which do not comply with applicable regulatory requirements, please exercise extra caution, to permanently consult the NAMMDR website for such information and to ensure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-19-05-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>19.05.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Medical Electric Saw Drill, Medical Electric Drill, Medical Electric Saw, Acerabulum Reamer, manufactured by Beijing Eaven Medical Instrument Co., Ltd., China<\/strong>, if they have come into possession of the falsified copy of the CE certificate of conformity no. G2 16 06 95446 003, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2018-11-08, valid until 2023-01-07.<br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices which do not comply with applicable regulatory requirements, please exercise extra caution, to permanently consult the NAMMDR website for such information and to ensure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-19-04-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>19.04.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Wrist Type Blood Pressure Monitor, Infrared Thermometer, Arm Type Blood Pressure Monitor, Fetal Doppler, Nebulizer, manufactured by Xuzhou Yongkang Electronic Science Technology Co., Ltd., China<\/strong>, if they have come into possession of a falsified copy of the EC certificate of conformity no. G2 092582 0010 Rev. 00, issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2019-11-26, valid until 2024-05-26, copy which includes all the aforementioned medical devices.<br \/>\nFor personal verification of the validity of the EC Certificate of Conformity held, we recommend interested parties to verify any information of this kind, posted by the issuing Notified Bodies on their own websites, such as:<br \/>\n<strong>T\u00dcV S\u00dcD Product Service GmbH, Germany (0123)<\/strong><br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\n(search criterion: second group of digits of the certificate number).<br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><br \/>\n<strong>T\u00dcV Rheinland LGA Products GmbH, Germany (0197)<\/strong><br \/>\nDatabase of issued certificates<br \/>\n<a href=\"https:\/\/www.certipedia.com\/\" target=\"_blank\">https:\/\/www.certipedia.com\/<\/a> (search criterion: second group of digits of the certificate number)<br \/>\nDatabase of falsified certificates<br \/>\n<a href=\"https:\/\/www.tuv.com\/world\/en\/black-list\/\" target=\"_blank\">https:\/\/www.tuv.com\/world\/en\/black-list\/<\/a><br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices which do not comply with applicable regulatory requirements, please exercise extra caution, to permanently consult the NAMMDR website for such information and to ensure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-28-02-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>28.02.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Oxigen Mask, Non-Rebreath Mask, Multi-vent Mask, Stomach Tube, Suction Catheter, Feeding Tube, Nasal Oxygen Cannula, Urethral Catheter without Balloon, Tracheostomy Mask, Aerosol Mask, Nebulizer, Disposable Air Cushion Face Mask, Nasal Jet Tube, Cricothyrotomy Kit, manufactured by Suzhou Ao Tech Co., Ltd., China<\/strong>, if they have come into possession of the falsified copy of the CE certificate of conformity no. G1 038800 0014 Rev.00 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2020-03-31, valid until 2024-05-26.<br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices which do not comply with applicable regulatory requirements, please exercise extra caution, to permanently consult the NAMMDR website for such information and to ensure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-17-01-2022\/\">Important notification<\/a><div class=\"content\"><p><strong>17.01.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all stakeholders (importers, distributors, users)<\/strong><\/span><br \/>\nThe NAMMDR warns all stakeholders not to introduce on the Romanian market or to use medical devices of type <strong>CoviSelf COVID-19 Antigen Lateral Flow Test Device OTC Home Test, manufactured by MyLab Discovery Solutions PVT LTD, India<\/strong>, for which they have received the falsified EC certificate of conformity no. 1434-IVDD-648\/2021 which would have been issued by Notified Body Polish Centre for Testing and Certification, Poland (1434) on 30.11.2021, valid until 30.11.2024.<br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, please check the NAMMDR website for such information and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-02-11-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>02.11.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Auto Disable Syringes, Burette Infusion Set; Insulin Syringes for Single Use, face Masks, manufactured by Changzhou Medical Appliances General Factory Co., Ltd., China<\/strong>, for which a falsified copy of the EC Certificate of Conformity No. DD 2183016-1 was detected on the EU market, issued by Notified Body T\u00dcV Rheinland LGA Products GmbH, Germany (0197) on 2020-11-30, valid until 2024-05-26.<br \/>\nFor personal verification of the validity of the EC Certificate of Conformity held, we recommend interested parties to verify any information of this kind, posted by the issuing Notified Bodies on their own websites, such as:<br \/>\n<strong>T\u00dcV S\u00dcD Product Service GmbH, Germany (0123)<\/strong><br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\n(search criterion: second group of digits of the certificate number).<br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><br \/>\nDatabase of issued certificates:<br \/>\nhttps:\/\/www.certipedia.com\/ (search criterion: second group of digits of the certificate number)<br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuv.com\/world\/en\/black-list\/\" target=\"_blank\">https:\/\/www.tuv.com\/world\/en\/black-list\/<\/a><br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, please check the NAMMDR website for such information and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-20-10-2021-2\/\">Important notification<\/a><div class=\"content\"><p><strong>20.10.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Contrast media injectors 4 connecting tube accessories, manufactured by Shenzhen Seacrown Electromechanical Co., Ltd., China<\/strong>, if they have come into possession of the falsified copy of the CE certificate of conformity no. 4545GB410200806 issued by Notified Body MEDCERT Zertifizierungs- und Pr\u00fcfungsgesellschaft f\u00fcr die Medizin GmbH, Germany (0482) on 2020-08-06, valid until 2024-05-27, copy that includes in the annex to the certificate, at the list of products\/product categories included in the scope of the certificate, precisely these types of medical devices.<br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, please check the NAMMDR website for such information and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-30-09-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>30.09.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type Electrocardiograph, Transcutaneous Jaundice Detector, Spirometer, Automatic External Defibrillator, manufactured by Guangzhou MeCan Medical Limited, China, if they have received the falsified EC certificate of conformity no. G1 067514 0018 Rev.00, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2019-01-09, valid until 2024-01-08.<br \/>\nFor personal verification of the validity of the EC Certificate of Conformity held, we recommend interested parties to verify any information of this kind, posted by the issuing Notified Bodies on their own websites, such as:<br \/>\nT\u00dcV S\u00dcD Product Service GmbH, Germany (0123)<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a> (search criterion: second group of digits of the certificate number).<br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/<\/a>liste-gefaelschter-zertifikate<br \/>\nT\u00dcV Rheinland LGA Products GmbH, Germany (0197)<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.certipedia.com\/\" target=\"_blank\">https:\/\/www.certipedia.com\/<\/a> (search criterion: second group of digits of the certificate number)<br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuv.com\/world\/en\/black-list\/\" target=\"_blank\">https:\/\/www.tuv.com\/world\/en\/black-list\/<\/a><br \/>\nTo prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, please check the NAMMDR website for such information and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-24-09-2021-2\/\">Important notification<\/a><div class=\"content\"><p><strong>24.09.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>DIAVUE ToGo Blood Glucose Monitoring System (including blood glucose meter, blood glucose test strips and control solutions), manufactured by BioCare Corporation, Taiwan<\/strong>, if they have come into possession of falsified certificate no. V1 077360 0016 Rev, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) for this manufacturer and device, on 2019-04-08, valid until 2022-01-22.<br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, please check the NAMMDR website for such information and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-24-09-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>24.09.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Disposable Anesthetic Breathing Circuits, Disposable Heat and Moisture Exchanger Filters, Disposable Tracheal Tubes, Disposable Oxygen Masks, Disposable Anesthetic Masks, Laryngeal Mask Airway, Disposable Manual Resuscitators, Disposable Heparin Cap, Disposable Suction Catheters, Disposable Three Way Stopcock, Latex Foley Catheters, Laryngoscope Blades, Wound Drainage System, Tracheostomy Tubes, Nelaton Catheters, Stomach Tubes, All Silicone Stomach Tubes, Feeding Tubes, Reinforced Endotracheal Tubes, Bacteria\/Viral Filters, Humidifier, Chest Drainage Bottle, Condom Catheters, Disposable Venturi Masks, Disposable Venturi Masks, Disposable Nebulizer Masks, Disposable Oxygen Masks with Reservoir Bags Nasal Oxygen Cannula, Disposable Syringe, Infusion Sets, Blood Transfusion Sets, Insulin Syringes, Hypodermic Needles, Blood Lancets, Extension Tubes, Disposable IV Catheters, Surgical Gloves, Surgical Suture, Digital Thermometers, Paraffin Gauze, Closed Suction System, Infusion Sets With Burette, Bubble Tubes, Connecting Tubes with Yankauer Handle, Spinal Needles, Tracheostomy Mask, Nebulizer Device, Electronic Sphygmomanometer, Infrared Thermometer, Fingertip Pulse Oximete, Disposable Electrosurgical Pencil; Rectal Tubes, Disposable Umbilical Cord Clamps, Surgical Brush, Disposable I.D. Bracelets, Disposable Air Ways, Disposable Urine Bag, Alcohol Swabs, Gauze Swabs, Gauze Bandage, Swabs, Non-woven Field, Apron, Medical Bandage, Suction Liner; Aneroid Sphygmomanometers manufactured by Ningbo Sintrue Medical Instruments Co., Ltd., China<\/strong>, if they have received the falsified EC certificate of conformity no. DD 60104785 0001 which would have been issued by Notified Body T\u00dcV Rheinland LGA Products GmbH, Germany (0197) on 2019-12-11, valid until 2022-11-26.<br \/>\n<strong>Or personal verification of the validity of the EC Certificate of Conformity held, we recommend checking the information contained in the following notification, posted on the website of the National Agency for Medicines and Medical Devices of Romania, section IMPORTANT NOTIFICATIONS &#8211; MEDICAL DEVICES:<br \/>\n04.09.2020<br \/>\nTo the attention of all stakeholders (contracting healthcare units, importers and distributors of medical devices and so on)<br \/>\nTo prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, please check the NAMMDR website for such information and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-04-08-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>04.08.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Oxygen concentrator \u2013 product name: LG102P, LG103, manufactured by Oxytek Medical Technology Co., Ltd., China<\/strong>, if they have received the falsified EC certificate of conformity no. 10014-2017-CE-RGC-NA-PS Rev 0.0 which would have been issued by Notified Body DNV GL Presafe AS, Norway (NB 2460) on 31.07.2018, valid until 31.07.2023.<br \/>\nThe valid certificate with no. 10014-2017-CE-RGC-NA-PS Rev 0.0 was issued by Notified Body DNV GL Presafe AS, Norway (NB 2460) for this manufacturer, on 31.07.2017, valid until 31.07.2022 and does not specify the LG102P and LG103 types of concentrators.<br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-19-07-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>19.07.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>SARS-CoV-2 (self-testing) Antigen Rapid Test Kit, manufactured by BEIJING LEPU MEDICAL TECHOLOGY, China<\/strong>, if they have received the falsified EC certificate of conformity no. MDD-YD-0335853, which would have been issued by Notified Body T\u00dcV Rheinland LGA Products GmbH, Germany (0197) on 2021-05-18, valid until 2025-05-18.<br \/>\n<strong>Or personal verification of the validity of the EC Certificate of Conformity held, we recommend checking the information contained in the following notification, posted on the website of the National Agency for Medicines and Medical Devices of Romania, section IMPORTANT NOTIFICATIONS &#8211; MEDICAL DEVICES:<br \/>\n04.09.2020<br \/>\nTo the attention of all stakeholders (contracting healthcare units, importers and distributors of medical devices and so on)<br \/>\nTo prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-10-06-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>10.06.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market <strong>medical devices manufactured by Surgi Edge, India, bearing the CE marking 2265<\/strong>, for which they have received a CE certificate of conformity which would have been issued by Notified Body 3EC International a.s., Slovakia (2265) for this manufacturer. According to the information made available to us, this manufacturer is not the client of Notified Body 3EC International a.s., Slovakia (2265) and does not own any valid EC certificate of conformity issued by this Body.<br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-08-06-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>08.06.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Medical examination gloves manufactured by Shandong Aobo Medical Instrument Co. Ltd., China<\/strong>, if they have received the falsified EC certificate of conformity no. 6706GB410171025 which would have been issued by Notified Body MEDCERT Zertifizierungs- und Pr\u00fcfungsgesellschaft f\u00fcr die Medizin GmbH, Germany (0482) on 2017-10-25, valid until 2022-03-14.<br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, please check the NAMMDR website for such information and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-04-06-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>04.06.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Laser therapy devices, Shockwave Therapy Machine, Smart Tecar, manufactured by Shenzhen Raycome Health Technology Co., China<\/strong>, if they have come into possession of the falsified copy of the CE certificate of conformity no. 7120GB410201209A issued by Notified Body MEDCERT Zertifizierungs- und Pr\u00fcfungsgesellschaft f\u00fcr die Medizin GmbH, Germany (0482) on 2020-12-09, valid until 2024-05-27, copy that includes in the annex to the certificate precisely these types of medical devices.<br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, please check the NAMMDR website for such information and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-24-05-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>24.05.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Thermometer, Pulse Oximeter, signs Monitor, Multiparameter Patient Monitor, manufactured by HEYUAN LEYUAN INTELLIGENT TECHNOLOGY CO.,LTD, China<\/strong>, if they have received the falsified EC certificate of conformity no. G1 076561 0010 Rev.00, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2020-03-02, valid until 2024-05-26.<br \/>\n<strong>Or personal verification of the validity of the EC Certificate of Conformity held, we recommend checking the information contained in the following notification, posted on the NAMMDR website, section IMPORTANT NOTIFICATION &#8211; MEDICAL DEVICES:<br \/>\n04.09.2020<br \/>\nTo the attention of all stakeholders (contracting healthcare units, importers and distributors of medical devices and so on)<br \/>\nTo prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, please check the NAMMDR website for such information and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-21-05-2021-3\/\">Important notification<\/a><div class=\"content\"><p><strong>21.05.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Sterile Gauze Swab with\/without X-Ray, Sterile Lap Sponge with\/without X-Ray, Sterile Lap Sponge with Barium Strip, Sterile Gauze Ball with\/without X-Ray, Infusion Set for Single Use(with Needle), Sterile Hypodermic Syringe for Single Use(with Needle), Disposable Sterile Hypodermic Needle, Oxygen Mask, Nebulizer Mask, Latex Surgical Gloves, manufactured by Shaoxing Medply Medical Products Co. Ltd., China<\/strong>, if they have come into possession of the falsified copy of the CE certificate of conformity no. G2 093943 0003 Rev.01 issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2021-02-14, valid until 2023-02-13.<br \/>\n<strong>Or personal verification of the validity of the EC Certificate of Conformity held, we recommend checking the information contained in the following notification, posted on the NAMMDR website, section IMPORTANT NOTIFICATION &#8211; MEDICAL DEVICES:<br \/>\n04.09.2020<br \/>\nTo the attention of all stakeholders (contracting healthcare units, importers and distributors of medical devices and so on)<br \/>\nTo prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, to permanently consult the NAMMDR website for such information and to make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-21-05-2021-2\/\">Important notification<\/a><div class=\"content\"><p><strong>21.05.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Surgical Drape, Surgical Gown, Surgical Pack, Latex Examination Glove, Nitrile Examination Glove, Medical Face Mask, Medical Cap, Medical Shoe Cover, Vaginal Speculum, manufactured by HeNan YADU Industrial Co., Ltd., China<\/strong>, if they have come into possession of the falsified copy of the CE certificate of conformity no. G2S 104411 0002 Rev. 00 issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2019-11-08, valid until 2024-05-26.<br \/>\n<strong>Or personal verification of the validity of the EC Certificate of Conformity held, we recommend checking the information contained in the following notification, posted on the NAMMDR website, section IMPORTANT NOTIFICATION &#8211; MEDICAL DEVICES:<br \/>\n04.09.2020<br \/>\nTo the attention of all stakeholders (contracting healthcare units, importers and distributors of medical devices and so on)<br \/>\nTo prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, to permanently consult the NAMMDR website for such information and to make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<br \/>\n<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-21-05-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>21.05.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Nitrile examination gloves, manufactured by Guangzhou Pidegree Medical Technology Co., Ltd., China<\/strong>, if they have received the falsified EC certificate of conformity no. 6706GB415100225, which would have been issued by Notified Body MEDCERT Zertifizierungs- und Pr\u00fcfungsgesellschaft f\u00fcr die Medizin GmbH, Germany (0482) on 2020-02-25, valid until 2025-11-09, in line with Annex II \u2013 Essential Requirements according to the PPE-Directive 89\/686\/EEC.<br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, please check the NAMMDR website for such information and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-10-05-2021-2\/\">Important notification<\/a><div class=\"content\"><p><strong>10.05.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Sterile Hypodermic Syringe for Single Use \u2013 Type: Hypodermic Syringe, Safety Syringe and Insulin Syringe, manufactured by International Company for Medical Necessities (I.CO), Egypt<\/strong>, for which a falsified copy of the CE Certificate of Conformity No. 2020-MDD\/QS-107 was detected on the EU market, issued by Notified Body 3EC International a.s., Slovakia (2265) on 2020-08-12, valid until 2024-05-26.<br \/>\nFor personal verification regarding the validity of the EC Certificate of conformity you own , please consult the information available on the website of the Notified Body 3EC International a.s., Slovakia, by accessing the links below:<br \/>\n<a href=\"https:\/\/www.3ec.sk\/en\/services\/falsificates\/\" target=\"_blank\">https:\/\/www.3ec.sk\/en\/services\/falsificates\/<\/a><br \/>\n<a href=\"https:\/\/www.3ec.sk\/en\/services\/suspension-or-withdrawal-of-certification\/\" target=\"_blank\">https:\/\/www.3ec.sk\/en\/services\/suspension-or-withdrawal-of-certification\/<\/a><br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-10-05-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>10.05.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Sterile Medical Syringes with Needles (Size: 1 ml, 3 ml (Infant), 3 ml (Adult), 5 ml, 10 ml), manufactured by SAS Co. for Syringes Manufacturing, Egypt<\/strong>, for which a falsified copy of the CE Certificate of Conformity No. 2018-MDD\/QS-011 was detected on the EU market, issued by Notified Body 3EC International a.s., Slovakia (2265) on 2018-06-13, valid until 2023-06-12.<br \/>\nFor personal verification regarding the validity of the EC Certificate of conformity you own , please consult the information available on the website of the Notified Body 3EC International a.s., Slovakia, by accessing the links below:<br \/>\n<a href=\"https:\/\/www.3ec.sk\/en\/services\/falsificates\/\" target=\"_blank\">https:\/\/www.3ec.sk\/en\/services\/falsificates\/<\/a><br \/>\n<a href=\"https:\/\/www.3ec.sk\/en\/services\/suspension-or-withdrawal-of-certification\/\" target=\"_blank\">https:\/\/www.3ec.sk\/en\/services\/suspension-or-withdrawal-of-certification\/<\/a><br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-21-04-2021-2\/\">Important notification<\/a><div class=\"content\"><p><strong>21.04.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of types <strong>Hy-Silk\u2122 Light, Hy-Silk\u2122 Deep, Hy-Silk\u2122 Ultra Deep and Crosslinked Hyaluronic Acid With Lidocaine With provision for Inclusion of Biocompatible Materials less than 2% Weight, manufactured by +Biio-P Pharmaceutical Manufacturing, Korea<\/strong>, if they have come into possession of the falsified CE certificates of conformity no. 1434-MDD-327\/2020 and no. 1434-MDD-328\/2020, which would have been issued by Notified Body Polish Centre for Testing and Certification, Poland (1434), valid from 27.08.2020 to 27.05.2024.<br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-21-04-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>21.04.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Sterile Gauze Swab with\/without X-Ray, Sterile Lap Sponge with\/without X-Ray, Sterile Lap Sponge with Barium Strip, Sterile Gauze Ball with\/without X-Ray, Infusion Set for Single Use(with Needle), Sterile Hypodermic Syringe for Single Use(with Needle), Disposable Sterile Hypodermic Needle, Oxygen Mask, Nebulizer Mask, Latex Surgical Gloves manufactured by Shaoxing Medply Medical Products Co. Ltd., China<\/strong>, if they have received the falsified EC certificate of conformity no. G2 093943 0003 Rev.01 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), valid from 2021-02-14 to 2023-02-13.<br \/>\n<strong>Or personal verification of the validity of the EC Certificate of Conformity held, we recommend checking the information contained in the following notification, posted on the website of the National Agency for Medicines and Medical Devices of Romania, section IMPORTANT NOTIFICATIONS &#8211; MEDICAL DEVICES:<br \/>\n04.09.2020<br \/>\nTo the attention of all stakeholders (contracting healthcare units, importers and distributors of medical devices and so on)<br \/>\nTo prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-12-04-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>12.04.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Soft Contact Lens, manufactured by YIWU QIAOTI E-commerce CO., LTD, China<\/strong>, if they have received the falsified EC certificate of conformity no. HD 60117242 0001, which would be issued for this manufacturer by Notified Body T\u00dcV Rheinland LGA Products GmbH, Germany (0197) on 2017-05-27, valid until 2022-03-15.<br \/>\n<strong>Or personal verification of the validity of the EC Certificate of Conformity held, we recommend checking the information contained in the following notification, posted on the website of the National Agency for Medicines and Medical Devices of Romania, section IMPORTANT NOTIFICATIONS &#8211; MEDICAL DEVICES:<br \/>\n04.09.2020<br \/>\nTo the attention of all stakeholders (contracting healthcare units, importers and distributors of medical devices and so on)<br \/>\nTo prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-29-03-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>29.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of importers and distributors of PCR tests and COVID-19 testing centers<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices in Romania warns all importers and distributors of PCR tests as well as COVID-19 testing centers that falsified PCR tests for COVID-19 detection, batch 04\/2020, item 0097654236, <strong>manufactured by SHENZHEN PHARMACEUTICAL CO. LTD., China, have been detected on the EU market<\/strong>.<br \/>\nIf you have come into possession of these products, accompanied by the document \u201dEC-Declaration of Conformity for CE-Marking accordion to Council Directive 98\/79\/EEC\u201d which would have been issued by TUV Rheinland LGA Products GmbH, Germany, which states:<br \/>\nDeclaration of conformity: Detection Test for Coronavirus disease 2020<br \/>\nCOVID-19 PCR RAPID TEST<br \/>\nGIVD CODE: 28.08.36.91<br \/>\nThe validity with the date of issue.<br \/>\nAugust 28, 2020<br \/>\nwith the CE 0373 marking visible on the plastic cover of the collection swab, <strong>do not use them and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service.<br \/>\nTo prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-22-03-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>22.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devicess<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>\u201dLatex and Nitrile Surgical Powder free Glove, Sterile \/ Trade mark: Superieur Gloves\u201d, manufactured by an unidentified manufacturer, Route 1, Long Thanh Industrial Zone Long Thanh District, Dong Nai Province 76211, Vietnam<\/strong>, if they have received the falsified EC certificate of conformity no. G2 0493 Rev. 03, which would be issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), valid from 2020-02-19 to 2024-07-28.<br \/>\n<strong>Or personal verification of the validity of the EC Certificate of Conformity held, we recommend checking the information contained in the following notification, posted on the website of the National Agency for Medicines and Medical Devices, section IMPORTANT NOTIFICATIONS \u2013 MEDICAL DEVICES:<br \/>\n04.09.2020<br \/>\nTo the attention of all stakeholders (contracting healthcare units, importers and distributors of medical devices and so on)<br \/>\nTo prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-11-03-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>11.03.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Cross-linked Hyaluronic Acid Dermal Filler with PDRN<\/strong>, for which a falsified copy of the CE Certificate of Conformity No. 2017-MDD\/QS-044 was detected on the EU market, issued by Notified Body 3EC International a.s., Slovakia (2265) on 2017-10-02, valid until 2022-10-01.<br \/>\n<strong>For personal verification regarding the validity of the EC Certificate of conformity you own, please consult the information posted on the website of Notified Body 3EC International a.s., Slovakia, by accessing the links below:<br \/>\n<a href=\"https:\/\/www.3ec.sk\/en\/services\/falsificates\/\" target=\"_blank\">https:\/\/www.3ec.sk\/en\/services\/falsificates\/<\/a><br \/>\n<a href=\"https:\/\/www.3ec.sk\/en\/services\/suspension-or-withdrawal-of-certification\/\" target=\"_blank\">https:\/\/www.3ec.sk\/en\/services\/suspension-or-withdrawal-of-certification\/<\/a><br \/>\nTo prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-26-02-2021-2\/\">Important notification<\/a><div class=\"content\"><p><strong>26.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Protective Clothing &#038; Equipment, Sterile NaCl-solutions \u2013 Physical acting products for the treatment of gastro-intestinal disorders \u2013 Physical acting products for the treatment of topical applications \u2013 Products for the treatment of dry eyes \u2013 Products for the treatment of vaginal disorders \u2013 Products for alleviation of haemorrhoidal disorders \u2013 Products for the treatment of sore throat, dry cough and hoarseness \u2013 Physically acting products for the application on mucous membranes, manufactured by Medi-Inn GmbH, Germany<\/strong>, if they have received the falsified EC certificate of conformity no. 3558GB414200519, which would be issued for this manufacturer by Notified Body MEDCERT Zertifizierungs- und Pr\u00fcfungsgesellschaft f\u00fcr die Medizin GmbH, Germany (0482), on 2020-05-19, valid until 2024-05-27.<br \/>\nThe rightful holder of the CE certificate of conformity no. 3558GB414200519, issued by Notified Body MEDCERT Zertifizierungs- und Pr\u00fcfungsgesellschaft f\u00fcr die Medizin GmbH, Germany (0482) on 2020-05-19, valid until 2024-05-27, is manufacturer H\u00e4lsa Pharma GmbH, Germany, for medical devices of type <strong>Isotonic NaCl-solutions \u2013 Sterile NaCl-solutions \u2013 Physical acting products for the treatment of gastro-intestinal disorders \u2013 Physical acting products for the treatment of topical applications \u2013 Products for the treatment of dry eyes \u2013 Products for the treatment of vaginal disorders \u2013 Products for alleviation of haemorrhoidal disorders \u2013 Products for the treatment of sore throat, dry cough and hoarseness \u2013 Physically acting products for the application on mucous membranes.<br \/>\nTo prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-26-02-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>26.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type Laser therapy devices \u2013 <strong>Laser probes, Pulsewave blood pressure monitors, manufactured by SHENZHEN AFKMED CO., LTD., China<\/strong>, if they have received the falsified EC certificate of conformity no. 7120GB410201209A, which would be issued for this manufacturer by Notified Body MEDCERT Zertifizierungs- und Pr\u00fcfungsgesellschaft f\u00fcr die Medizin GmbH, Germany (0482), on 2020-12-09, valid until 2024-05-27.<br \/>\nThe rightful holder of the CE certificate of conformity no.. 7120GB410201209A, issued by Notified Body MEDCERT Zertifizierungs- und Pr\u00fcfungsgesellschaft f\u00fcr die Medizin GmbH, Germany (0482) on 2020-12-09, valid until 2024-05-27, is manufacturer by Shenzhen Raycome Health Technology Co., China.<br \/>\n<strong>To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><li class=\"listing-item\"><a class=\"title\" href=\"https:\/\/www.anm.ro\/en\/important-notification-19-02-2021\/\">Important notification<\/a><div class=\"content\"><p><strong>26.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>\u201dNon Sterile Latex Surgical Gloves(Powdered &#038; Powder Free)Latex Examination Gloves( Powdered &#038; Powder Free), Nitrile Examination Gloves( Powdered &#038; Powder Free), Plastic Gloves, Vinyl Gloves, Household Gloves, Disposable Mask, Cap, Apron, Gowns, Shoe cover &#038; Leggings\u201d, manufactured by John Holbert Medical Holding, Poland<\/strong>, if they have received the falsified EC certificate of conformity no. G2S 12 03 62218 009, which would be issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), valid from 2020-03-21 to 2023-04-17.<br \/>\n<strong>Or personal verification of the validity of the EC Certificate of Conformity held, we recommend checking the information contained in the following notification, posted on the website of the National Agency for Medicines and Medical Devices of Romania, section IMPORTANT NOTIFICATIONS &#8211; MEDICAL DEVICES:<br \/>\n04.09.2020<br \/>\nTo the attention of all stakeholders (contracting healthcare units, importers and distributors of medical devices and so on)<br \/>\nTo prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n<\/div><\/li><\/ul><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":469,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-11559","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/11559","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/comments?post=11559"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/11559\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/469"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11559"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}