{"id":11694,"date":"2026-02-09T08:00:57","date_gmt":"2026-02-09T05:00:57","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11694"},"modified":"2026-02-16T09:44:06","modified_gmt":"2026-02-16T06:44:06","slug":"important-notification-09-02-2026","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-09-02-2026\/","title":{"rendered":"Important notification"},"content":{"rendered":"<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","protected":false},"excerpt":{"rendered":"<p>09.02.2026 To the attention of all importers, distributors and users of medical devices The NAMMDR warns all importers and distributors [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26],"tags":[],"class_list":["post-11694","post","type-post","status-publish","format-standard","hentry","category-dispozitive-medicale-falsificate"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11694","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/post"}],"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=11694"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11694\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11694"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11694"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11694"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}