{"id":11721,"date":"2022-12-12T08:00:50","date_gmt":"2022-12-12T05:00:50","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11721"},"modified":"2026-02-23T14:29:53","modified_gmt":"2026-02-23T11:29:53","slug":"important-notification-12-12-2022-2","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-12-12-2022-2\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>12.12.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: <strong>Integral Dental Unit, manufactured by Foshan Nanhai Hager Medical Machinery Co., Ltd., PEOPLE\u2019S REPUBLIC OF CHINA<\/strong> if they have come into possession of the falsified copy of the CE certificate of conformity no. G2 058482 0010 Rev. 00 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2020-07-07, valid until 2025-07-06 for this manufacturer.<br \/>\nThe valid certificate, with the same number and for the same medical device category, issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) belongs to manufacturer <strong>Foshan Anle Medical Apparatus Co., Ltd., People\u2019s Republic of China<\/strong>.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Integral Dental Unit<\/strong> from manufacturer <strong>Foshan Nanhai Hager Medical Machinery Co., Ltd., PEOPLE\u2019S REPUBLIC OF CHINA<\/strong>, do not use them or make them available on the market and notify the National Agency for Medicines and Medical Devices of Romania \u2013 the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor personal verification, we recommend interested parties to check this information on the website of Notified Body, T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), by accessing the links below:<br \/>\nDatabase of issued certificates<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<\/a><br \/>\nDatabase of falsified certificates<br \/>\n<a href=\"https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate\" target=\"_blank\">https:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>12.12.2022 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-11721","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\/11721","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=11721"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11721\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11721"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11721"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11721"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}