09.02.2026
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type ‘Laryngeal 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’, accompanied by a falsified copy of CE certificate of conformity no. G2.086250.0018 Rev.01, which would have been issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2022-01-06 and valid until 2027-05-26.
The valid CE Certificate of Conformity with No. G2.086250.0018 Rev.01 was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2020-01-08, valid until 2024-05-26, for ‘Laryngeal 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’ and belongs to manufacturer Ningbo Luke Medical Devices Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell ‘Laryngeal 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’ 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 – the Market Surveillance Service, using the contact details posted on the NAMMDR website.
For your own verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

02.02.2026
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market ‘Dental Unit’ 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 TÜV SÜD 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.
The valid CE Certificate of Conformity with No. G2 17 02 83445 004 was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2017-07-10, valid until 2022-07-09 for ‘Dental Unit’ and belongs to manufacturer Foshan Hongke Medical Instrument Factory, China.
If 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For your own verification, we recommend that interested parties consult the information posted on the website of the Notified Body, TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

29.01.2026
To the attention of all importers, distributors and users of medical devices
The 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 TÜV SÜD Product Service GmbH (0123) on 2024-06-03 and valid until 2026-06-02.
The valid CE Certificate of Conformity with No. G1.098883.0002 Rev.02 was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2019-09-03, valid until 2024-05-26 for ‘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’ and belongs to manufacturer Neusoft Medical Systems Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell ‘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’ 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For personal verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

29.01.2026
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market ‘Human chorionic gonadotropin Colloidal gold test, Human Luteinizing hormone Colloidal gold test, Fecal Occult Blood Colloidal gold test’ accompanied by a falsified copy of CE certificate of conformity no. V1 084924 0002 Rev. 02, which would have been issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2018-11-30 and valid until 2025-10-10.
The valid CE Certificate of Conformity with No. V1.084924.0002.Rev.01 was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2018-11-30, valid until 2023-10-10 for ‘Human chorionic gonadotropin Colloidal gold test, Human Luteinizing hormone Colloidal gold test, Fecal Occult Blood Colloidal gold’ test and belongs to manufacturer Hubei MEIBAO Biotechnology Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell ‘Human chorionic gonadotropin Colloidal gold test, Human Luteinizing hormone Colloidal gold test, Fecal Occult Blood Colloidal gold test’ 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For personal verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

23.01.2026
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market ‘Sterile Non-active Medical Devices’ 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 TÜV SÜD Product Service GmbH (0123) on 2021-04-29 and valid until 2025-05-26 for this manufacturer.
The valid CE Certificate of Conformity with No. G2 001281 0001 Rev. 02 was issued by Notified Body TÜV SÜD 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.
If 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 – the Market Surveillance Service, using the contact details posted on the NAMMDR website.
For your own verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

19.01.2026
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices type ‘Infusion Set, Lap Sponges, Sterile Medication Set, Gauze Swabs without X-ray Thread, Gauze Swabs with X-ray, Non-woven Swabs with X-ray Thread’, 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 TÜV SÜD Product Service GmbH (0123) on 2017-11-17 and valid until 2024-11-16 for this manufacturer.
The valid CE Certificate of Conformity with No. G2 17 07 99160 003 was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2017-11-17, valid until 2022-11-16 for ‘Infusion Set, Lap Sponges, Gauze Swabs without X-ray Thread, Gauze Swabs with X-ray, Sterile Non-woven Swabs with X-ray Thread’ and belongs to manufacturer Bluemed Healthcare Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ‘Infusion Set, Lap Sponges, Sterile Medication Set, Gauze Swabs without X-ray Thread, Gauze Swabs with X-ray, Non-woven Swabs with X-ray Thread’ 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.
Database of issued certificates: For your own verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

19.06.2025
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type ‘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’ accompanied by the falsified CE certificate no. Q6 073425 0011 Rev. 02, which would have been issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2022-09-06 and valid until 2025-09-05.
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 TÜV SÜD Product Service GmbH, Germany in accordance with the requirements of standard EN ISO 13485:2016 – Medical devices — Quality management systems — Requirements for regulatory purposes for ‘Production 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’.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ‘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’ 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For your own verification, we recommend that interested parties consult the information posted on the website of Notified Body, TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

18.06.2025
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type ‘Disposable Airways, Urine Bag, Vaginal Speculum, Sterile Wound Plaster’ accompanied by a falsified copy of CE certificate of conformity no. G2S 104356 0003 Rev.01, which would have been issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2023-02-09 and valid until 2025-12-29.
The valid CE certificate of conformity with no. G2S 104356 0003 Rev.01 was issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2021-05-03, valid until 2024-05-26, for ‘Disposable Airways, Urine Bag, Vaginal Speculum, Sterile Wound Plaster’ and belongs to manufacturer Ningbo Great Mountain Medical Instruments Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell ‘Disposable Airways, Urine Bag, Vaginal Speculum, Sterile Wound Plaster’ 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For your own verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

18.06.2025
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type ‘Ligation Clips for Single Use’ accompanied by a falsified copy of CE certificate of conformity no. HD 60104799 0001, which would have been issued by Notified Body TÜV Rheinland LGA Products GmbH, Germany (0197) on 2023-02-02 and valid until 2028-01-01.
The valid CE Certificate of Conformity with No. HD 60104799 0001, issued by Notified Body TÜV 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.
If you have come into possession of such medical devices or are aware of distributors who sell ‘Ligation Clips for Single Use’ on the Romanian territory based on a falsified copy of the EC certificate of conformity no. HD 60104799 0001, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For your own verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV Rheinland LGA Products GmbH, Germany (0197), by accessing the links below:
– database with valid certificates: https://www.certipedia.com/?locale=en
– database with falsified certificates: https://www.tuv.com/world/en/warning-list/

18.06.2025
To the attention of all importers, distributors and users of medical devices
18.06.2025
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type ‘Pulse Oximeter, SPO2 Sensor, Patient Monitor’ accompanied by a falsified copy of CE certificate of conformity no. G1 087056 0005 Rev. 02, which would have been issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2024-05-15 and valid until 2028-12-31.
The valid CE certificate of conformity with no. G1 087056 0005 Rev. 02 was issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2019-05-16, valid until 2024-05-15, for ‘SPO2 Monitor, Pulse Oximeter, Spo2 Sensor, Patient Monitor’ and belongs to manufacturer Shanghai Berry Electronic Tech Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell ‘Pulse Oximeter, SPO2 Sensor, Patient Monitor’ 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For your own verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

17.06.2025
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type ‘Clinical Electronic Thermometers – Infrared Ear/Forehead Thermometers – Infrared Ear Thermometers – Infrared Forehead Thermometers – Nerve and Muscle Stimulators – Electrical Acupuncture Stimulators – Transcutaneous Electrical Nerve Stimulators – Electrical Muscle Stimulators – Electrical Neuromuscular Incontinence Stimulators – Ultrasound Physical Therapy Devices – Ultrasound and Electrical Neuromuscular Stimulators – Magnetic Stimulators – Electromagnetic Stimulators – Stimulation Electrodes – Electromyograph (EMG) Biofeedback Device – Electromyograph (EMG) Biofeedback and Neuromuscular Stimulator – Shortwave Therapy Devices – Laser Therapy Devices’ accompanied by a falsified copy of CE certificate of conformity no. HD 60147882 0001, which would have been issued by Notified Body TÜV Rheinland LGA Products GmbH (0197) on 2021-06-03 and valid until 2025-06-21.
The valid EC Certificate of Conformity with No. HD 60147882 0001 HD 60147882 0001 was issued by Notified Body TÜV 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.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ‘Clinical Electronic Thermometers – Infrared Ear/Forehead Thermometers – Infrared Ear Thermometers – Infrared Forehead Thermometers – Nerve and Muscle Stimulators – Electrical Acupuncture Stimulators – Transcutaneous Electrical Nerve Stimulators – Electrical Muscle Stimulators – Electrical Neuromuscular Incontinence Stimulators – Ultrasound Physical Therapy Devices – Ultrasound and Electrical Neuromuscular Stimulators – Magnetic Stimulators – Electromagnetic Stimulators – Stimulation Electrodes – Electromyograph (EMG) Biofeedback Device – Electromyograph (EMG) Biofeedback and Neuromuscular Stimulator – Shortwave Therapy Devices – Laser Therapy Devices’ based on the falsified copy of CE certificate of conformity no. HD 60147882 0001 HD 60147882 0001, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.

19.08.2024
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: ’Radio-Frequency assisted liposuction systems’ 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.
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.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Radio-Frequency assisted liposuction systems’ based on the falsified copy of certificate no. 2120853CE01, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.

08.08.2024
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: Hyperbaric Oxygen Treatment Systems (Hyperbaric Oxygen Chamber) – Multiplace Omega, Multiplace Cylindirical, Multiplace Quadro, Monoplace accompanied by falsified CE certificate no. 2195-MED-401431701 which would have been issued by Notified Body Szutest Uygunluk Değerlendirme A.Ş., Turkey (2195) on 2014-11-13, revised on 2019-11-12 and valid until 2025-05-26 for manufacturer Oxycare Prefabrik Mobil Çözümler Sanayi İthalat İhracat Ticaret Limited Şirketi, Turkey.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Hyperbaric Oxygen Treatment Systems (Hyperbaric Oxygen Chamber) – Multiplace Omega, Multiplace Cylindirical, Multiplace Quadro, Monoplace, based on the falsified certificate, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.

21.06.2024
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: ’UNIQA Dental Implants- Systems: Dental Implants, Dental Abutments and Superstructures’ manufactured by UNIQA Dental Ltd., Israel, 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.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’UNIQA Dental Implants- Systems: Dental Implants, Dental Abutments and Superstructures’ from manufacturer UNIQA Dental Ltd., Israel, based on the falsified copy of the CE certificate, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
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.
For 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:
https://www.mdc-ce.de/downloads/mdc-documents/lists-of-certificates.html?L=

21.06.2024
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: ’Diagnostic Ultrasound Systems, Wireless Probe Type Ultrasound Scanner’ manufactured by Sonostar Technologies Co., Ltd., China, 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 TÜV SÜD Product Service GmbH, Germany (0123) on 2019-08-30.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Diagnostic Ultrasound Systems, Wireless Probe Type Ultrasound Scanner’ from manufacturer Sonostar Technologies Co., Ltd., China, based on the falsified copy of the CE certificate, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
The valid certificate, held by this manufacturer, had the same number, was issued by Notified Body TÜV SÜD 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.
For personal verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

12.06.2024
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: ’Diagnostic Ultrasound Systems, Wireless Probe Type Ultrasound Scanner’ manufactured by Sonostar Technologies Co., Ltd., China, 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 TÜV SÜD Product Service GmbH, Germany (0123) on 2018-08-30.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Diagnostic Ultrasound Systems, Wireless Probe Type Ultrasound Scanner’ from manufacturer Sonostar Technologies Co., Ltd., China, based on the falsified copy of the CE certificate, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
The valid certificate, held by this manufacturer, had the same number, was issued by Notified Body TÜV SÜD 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.
For personal verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

30.05.2024
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: ’Self tests – 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)’ manufactured by Jei Daniel (JD) Biotech Corp., China, 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 TÜV SÜD Product Service GmbH, Germany (0123) on 2020-08-16, valid from 2020-09-04 to 2025-09-03 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Self tests – 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)’ from manufacturer Jei Daniel (JD) Biotech Corp., China, based on the falsified copy of the CE certificate, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
The valid certificate, held by this manufacturer, has the same number, was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), valid from 2018-09-04 to 2023-09-03 and covers only the following product categories: Self tests – 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.
For personal verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

28.05.2024
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: ’Patient 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’ accompanied by the falsified copy of CE certificate of conformity no. G1 18 03 44751 113, which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2018-07-09, valid until 2025-02-21.
The valid CE Certificate of Conformity with No. G1 18 03 44751 113, issued by Notified Body TÜV SÜD 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.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Patient 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’ based on the falsified copy of certificate no. G1 18 03 44751 113, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For personal verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

09.05.2024
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: ’Intense Pulsed Light for medical use + Diode Laser Equipment for medical use, CO2 Fractional Laser Equipment for medical use’ manufactured by Beijing Globalipl Development Co., Ltd., China, 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 TÜV SÜD Product Service GmbH, Germany (0123) on 2023-10-28, valid until 2027-12-31.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Intense Pulsed Light for medical use + Diode Laser Equipment for medical use, CO2 Fractional Laser Equipment for medical use’ from manufacturer Beijing Globalipl Development Co., Ltd., China, based on the falsified copy of the CE certificate, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
The valid certificate, held by this manufacturer, has the same number and was initially issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2018-12-07, valid until 2023-10-27, for the same product categories.
For personal verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

08.05.2024
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: ’Dental Unit’ manufactured by Foshan Hongke Medical Instrument Factory, China, 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 TÜV SÜD Product Service GmbH, Germany (0123) on 2019-07-10, valid until 2025-07-09 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Dental Unit’ from manufacturer Foshan Hongke Medical Instrument Factory., China, based on the falsified copy of the CE certificate, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
The valid certificate, held by this manufacturer, has the same number, was issued for the same product categories by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2017-07-10 and was withdrawn on 2022-05-16 upon manufacturer’s request.
For personal verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the Database of falsified certificates at the following link
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate.

08.05.2024
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: Autoclave, Hydrogen peroxide plasma sterilizer, Ethylene oxide sterilizer, Low temperature steam formaldehyde sterilizer, Washer-disinfector manufactured by Hongshun Medical Instrument Co., Ltd., China 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 TÜV SÜD Product Service GmbH, Germany (0123) on 2024-01-17, valid until 2029-01-16, for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory 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, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For personal verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the Database of falsified certificates at the following link
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate.

30.01.2024
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: ’Blood Collection Needles for Single Use, Disposable Blood Lancets, Disposable Safety Lancets’ manufactured by Liuyang Sanli Medical Technology Development Co.,Ltd., China, 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 TÜV SÜD Product Service GmbH, Germany (0123) on 2019-07-31, valid until 2024-07-30 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Blood Collection Needles for Single Use, Disposable Blood Lancets, Disposable Safety Lancets’ from manufacturer Liuyang Sanli Medical Technology Development Co.,Ltd., China, based on the falsified certificate, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
The valid certificate held by this manufacturer has the same number and was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), on 31.07.2018, valid until 30.07.2023 for the same product categories.
For personal verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

30.01.2024
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: Pulse oximeters, Vital signs monitors, Patient monitors manufactured by Zhuhai Topwinner Meditech Limited., China, 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.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Pulse oximeters, Vital signs monitors, Patient monitors from manufacturer Zhuhai Topwinner Meditech Limited., China, based on the falsified certificate, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.

30.01.2024
To the attention of all importers, distributors and users of medical devices
The 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: ’FinесаrеTM Fully-Automatic FlA Analyzer’ manufactured by Guangzhou Wondfo Biotech Co., Ltd., China, 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 TÜV SÜD Product Service GmbH, Germany (0123) on 2021-08-12, valid until 2024-04-20 for this manufacturer.
If you have come into possession of such in vitro diagnostic medical devices or are aware of distributors who sell: ’FinесаrеTM Fully-Automatic FlA Analyzer’ from manufacturer Guangzhou Wondfo Biotech Co., Ltd., China, on Romanian territory, based on the falsified certificate, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
The valid certificate held by this manufacturer has the same number and was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), on 2021-08-12 and is valid until 2026-08-11 for the following product categories:
FinecareTM CRP Test W201P0010
FinecareTM CRP Test W201P0011
FinecareTM HbA1c Test W207-C7PM
For personal verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

26.01.2024
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: 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, 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.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory 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, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.

23.01.2024
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type ’dental products, otoplastic products – 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’, manufactured by DETAX GmbH & Co. KG, Germany, 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.
The valid certificate issued by Notified Body mdc medical device certification GmbH, Germany (0483) for manufacturer DETAX GmbH & Co. KG, Germany has the same identification number and different dates of issue and expiry, 05.05.2021 and 26.05.2024.
If 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For 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:
https://www.mdc-ce.de/downloads/mdc-documents/lists-of-certificates.html?L=

18.12.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: ’Latex Gloves, Vinyl Gloves, Nitrile Gloves (For single use)’ manufactured by Taiyu Gloves CO., Limited, China, 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 TÜV SÜD Product Service GmbH, Germany (0123) on 2022-11-29, valid until 2025-11-28 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Latex Gloves, Vinyl Gloves, Nitrile Gloves(For single use)’ from manufacturer Taiyu Gloves CO., Limited, China, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For personal verification, we recommend that interested parties consult the information on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

14.12.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: ’Disposable Latex Surgical Gloves, Disposable Latex Examination Gloves’ manufactured by Pidegree Industrial Co.,Limited., China, 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 TÜV SÜD Product Service GmbH, Germany (0123) on 2020-03-04, valid until 2024-05-26 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Disposable Latex Surgical Gloves’, ‘Disposable Latex Examination Gloves’ from manufacturer Pidegree Industrial Co., Limited., China, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
The valid certificate with the same identification data, namely number, date of issue and expiry and belonging to product category ‘Disposable Latex Surgical Gloves’, was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), for manufacturer Tianchang Hengsheng Medical Devices Co.,Ltd., China.
For personal verification, we recommend that interested parties consult the information on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

14.12.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: ’Dental Suction Systems’ manufactured by Suzhou Junwei Medical Equipment Co., Ltd., China, 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 TÜV SÜD Product Service GmbH, Germany (0123) on 2023-05-25, valid until 2025-05-24, for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Dental Suction Systems from manufacturer Suzhou Junwei Medical Equipment Co., Ltd., China, based on the falsified certificate, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
Atragem atenția părților interesate că, potrivit informațiilor intrate în posesia ANMDMR, în afara certificatului falsificat mai sus menționat, pentru acest producător mai există pe piața UE și certificatul falsificat nr. Q8 082551 0003 Rev. 01 which would have been issued by Certifying Body TÜV SÜD Product Service GmbH, Germany on 2022-04-25, valid until 2025-04-24 in accordance with the requirements of standard EN ISO 13485:2016 – Quality management systems. Requirements for regulatory purposes for Design and Development, Production and Distribution of Medical Oil Free Air Compressors, Dental Suction Systems.
For personal verification, we recommend that interested parties consult the information on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

13.12.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: ’Medical Natural Rubber Latex Examination Glove’, ‘Examination Synthetic Rubber Latex Examination Glove’, ‘Disposable Synthetic Rubber Latex Surgical Glove’, manufactured by Ace Glove(M) Sdn. Bhd., Malaysia, 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 TÜV SÜD Product Service GmbH, Germany, in accordance with the requirements of standard EN ISO 13485:2016 – Quality management systems, QMS regulatory requirements, on 2023-05-01, valid until 2026-04-30, for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory 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, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
The valid certificate with the same identification data, namely number, issue and expiry date was issued by Certifying Body TÜV SÜD Product Service GmbH, Germany for manufacturer Top Glove Sdn. Bhd. Malaysia, for:
– Design and Development, Manufacture and Distribution of:
1. Non-Sterile Natural Rubber Latex Examination Glove
2. Non-Sterile Synthetic Rubber Latex Examination Glove
– Manufacture and Distribution of:
1. Sterile Synthetic Rubber Latex Surgical Glove.
For personal verification, we recommend that interested parties consult the information on the website of Notified Body, TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

08.11.2023
To the attention of all importers, distributors and users of medical devices
The 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 TÜV SÜD 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.
The valid certificate, issued by Notified Body TÜV SÜD 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 – 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.
We 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 TÜV SÜD Product Service GmbH, Germany on 2022-07-06 valid until 2025-01-26 in accordance with the requirements of standard EN ISO 13485:2016 – Quality management systems. Requirements for regulatory purposes for Production and Distribution of Medical Devices – 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.
If 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For personal verification, we recommend that interested parties consult the information on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

30.10.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: Blood glucose monitoring systems (B12, B12 LAEN, B13, B14, B15, B16, B17, B18, B19) manufactured by Prolinx GmbH, Germany, 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.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Blood glucose monitoring systems (B12, B12 LAEN, B13, B14, B15, B16, B17, B18, B19) from manufacturer Prolinx GmbH, Germany, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For 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:
https://www.mdc-ce.de/downloads/mdc-documents/lists-of-certificates.html

02.10.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market Patient Monitoring Devices, Defibrillator/Monitor, Electrocardiograph, Anesthesia Machine, Ultrasonic Diagnostic Equipment, Digital radiography System manufactured by PT. Mindray Medical Indonesia, Indonesia, 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 TÜV SÜD Product Service GmbH, Germany (0123), on 2020-09-17, valid until 2025-02-21 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Patient Monitoring Devices, Defibrillator/Monitor, Electrocardiograph, Anesthesia Machine, Ultrasonic Diagnostic Equipment, Digital radiography System from manufacturer PT. Mindray Medical Indonesia, Indonesia, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
We 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:
– 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 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
– Certificate no. Q1N 11 05 44751 057 which would have been issued by Notified Body TÜV SÜD 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 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
For personal verification, we recommend that interested parties consult the information on the website of Notified Body, TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Baza de date cu certificate:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

27.09.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type ’One Step Rapid Diagnostic Step – 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)’, 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.
The valid certificate with the same identification data, namely number, product categories, issue and expiry date One Step Rapid Diagnostic Test – 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.
If 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For 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:
Database of falsified certificates: https://www.3ec.sk/en/services/falsificates/

25.09.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: Diode laser hair removal machine for medical use manufactured by Beijing Lead Beauty S & T Co. Ltd., People’s Republic of China, 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 TÜV SÜD Product Service GmbH, Germany (0123), on 2020-02-17, valid until 2024-05-26 for this manufacturer.
The valid certificate, with the same identification data, namely number, issuance and expiry date and medical devices categories ‘Diode laser hair removal machine for medical use, Intense pulsed light therapy device (IPL) for medical use’, was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), for manufacturer Beijing Nubway S & T Co., Ltd., People’s Republic of China.
If 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 & T Co. Ltd., People’s 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For personal verification, we recommend that interested parties consult the information on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Baza de date cu certificate:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

07.08.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: Hip Implants, Bipolar Head manufactured by OHST Medizintechnik AG, Germany, 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.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Hip Implants, Bipolar Head from manufacturer OHST Medizintechnik AG, Germany, 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.

07.08.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: Hip Implants, Bipolar Head manufactured by OHST Medizintechnik AG, Germany, 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.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Hip Implants, Bipolar Head from manufacturer OHST Medizintechnik AG, Germany, 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.

07.08.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: Oral Dispenser – 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, 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.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Oral Dispenser – 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, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.

21.07.2023
To the attention of all interested parties (importers, distributors, users – health units and patients)
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: 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.
The 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.
We hereby warn state and private healthcare facilities as well as patients not to use intraarticular medical devices ‘Sodium hyaluronate injection, Cross-Linked Sodium Hyaluronate Injection brand 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 them and to notify the National Agency for Medicines and Medical Devices of Romania – 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.

07.06.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: Blood pressure monitors, thermometers, suction, nebulizers, digital color doppler, hearing aids manufactured by Prolinx GmbH(ALPHA), Germany, 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.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Blood pressure monitors, thermometers, suction, nebulizers, digital color doppler, hearing aids from manufacturer Prolinx GmbH(ALPHA), Germany, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For 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:
Database of falsified certificates:
https://www.mdc-ce.de/fileadmin/user_upload/Downloads/mdc-Dokumente/Kundenlisten/Gef%C3%A4lschte_Zertifikate_List_of_forged_certificates_2023-06-01.pdf

24.04.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: Oxidized regenerated cellulose – Equicel and Equitamp, manufactured by EQUIMEDICAL BV, the Netherlands, 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.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Oxidized regenerated cellulose – Equicel and Equitamp, manufactured by EQUIMEDICAL BV, the Netherlands, 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.
We 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. 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. 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.
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.

10.04.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: 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, 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 TÜV SÜD Product Service GmbH, Germany (0123), on 2020-03-13, valid until 2023-06-27 for this manufacturer.
If 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 – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For personal verification, we recommend that interested parties consult the information posted on the website of Notified Body, TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

31.03.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type Blood separating kit, manufactured by Glofinn Co., Ltd., Republic of Korea, 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 TÜV SÜD Product Service GmbH, Germany (0123), on 2022-08-10, valid until 2024-08-10 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Blood separating kit from manufacturer Glofinn Co., Ltd., Republic of Korea, do not place them on the market and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For personal verification, we recommend that interested parties consult the information posted on the website of Notified Body, TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate

31.03.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: Infusion Pump, Syringe Pump Infusion Warmer, Patient Warming Machine, manufactured by Jiangsu Sinowise Technology Co., Ltd., People’s Republic of China, 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 TÜV SÜD Product Service GmbH, Germany (0123) on 2021-04-23, valid until 2024-05-26 for this manufacturer.
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 TÜV SÜD Product Service GmbH, Germany(0123), for manufacturer Dongguan HEPHO Medical Science Technology Co., LTD., People’s Republic of China.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Infusion Pump, Syringe Pump Infusion Warmer, Patient Warming Machine from manufacturer Jiangsu Sinowise Technology Co., Ltd., People’s Republic of China, do not place them on the market and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For personal verification, we recommend that interested parties consult the information posted on the website of Notified Body, TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate