{"id":11717,"date":"2023-03-23T08:00:05","date_gmt":"2023-03-23T05:00:05","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11717"},"modified":"2026-02-23T14:25:53","modified_gmt":"2026-02-23T11:25:53","slug":"important-notification-23-03-2023","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-23-03-2023\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>23.03.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices of Romania warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type \u201dSterile Gauze Swab with X-Ray, Sterile Lap Sponge, Sterile Surgical Gloves, Foley Catheter (Latex), Nelaton Catheter, Endotracheal Tubes, Disposable Syringes, Disposable Infusion Sets, Disposable Blood Transfusion Sets, Disposable Scalp Vein Sets, Disposable Hypodermic Needles, Disposable Surgical Blades, Sterile Scalpel with Plastic Handle, Suction Catheter, Feeding Tube, Stomach Tube, Extension Tube\/Connecting Tube\u201d, if they have come into possession of the falsified copy of the CE certificate of conformity no. G2.054580.0019.Rev.01, valid from 2019-09-04 to 2024-05-26, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), for any other manufacturer except for Hygeia Medical Co., Ltd., Shanghai, People\u2019s Republic of China.<br \/>\nThe valid certificate, with the same identification data, namely number, medical device category, issue and expiry date, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), for manufacturer Hygeia Medical Co., Ltd., Shanghai, People\u2019s Republic of China.<br \/>\nIf you have come into possession of such medical devices, for which you were shown the falsified copy of the CE certificate of conformity no. G2.054580.0019.Rev.01, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend that interested parties consult the information posted on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nBaza de date cu certificate:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates:<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>23.03.2023 To the attention of all importers, distributors and users of medical devices The National Agency for Medicines and Medical [&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-11717","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\/11717","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=11717"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11717\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11717"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11717"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11717"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}