{"id":11567,"date":"2025-06-18T10:00:59","date_gmt":"2025-06-18T07:00:59","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11567"},"modified":"2026-01-30T10:29:57","modified_gmt":"2026-01-30T07:29:57","slug":"important-notification-18-06-2025-3","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-18-06-2025-3\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>18.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market medical devices of type <strong>\u2018Disposable Airways, Urine Bag, Vaginal Speculum, Sterile Wound Plaster\u2019<\/strong> accompanied by a falsified copy of CE certificate of conformity no. G2S 104356 0003 Rev.01, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2023-02-09 and valid until 2025-12-29.<br \/>\n<strong>The valid CE certificate of conformity with no. G2S 104356 0003 Rev.01 was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2021-05-03, valid until 2024-05-26, for \u2018Disposable Airways, Urine Bag, Vaginal Speculum, Sterile Wound Plaster\u2019 and belongs to manufacturer Ningbo Great Mountain Medical Instruments Co., Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell <strong>\u2018Disposable Airways, Urine Bag, Vaginal Speculum, Sterile Wound Plaster\u2019<\/strong> on the Romanian territory based on the falsified copy of the EC certificate of conformity no. G2S 104356 0003 Rev.01, do not use them and notify the National Agency for Medicines and Medical Devices of Romania &#8211; the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor your own verification, we recommend that interested parties consult the information posted on the website of Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>18.06.2025 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-11567","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\/11567","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=11567"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11567\/revisions"}],"predecessor-version":[{"id":11573,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11567\/revisions\/11573"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11567"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11567"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11567"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}