{"id":11627,"date":"2024-01-30T08:00:48","date_gmt":"2024-01-30T05:00:48","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11627"},"modified":"2026-02-06T11:58:57","modified_gmt":"2026-02-06T08:58:57","slug":"important-notification-30-01-2024","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-30-01-2024\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>30.01.2024<\/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 in vitro diagnostic medical devices of type: <strong>\u2019Fin\u0435\u0441\u0430r\u0435TM Fully-Automatic FlA Analyzer\u2019 manufactured by Guangzhou Wondfo Biotech Co., Ltd., China<\/strong>, 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 T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2021-08-12, valid until 2024-04-20 for this manufacturer.<br \/>\nIf you have come into possession of such in vitro diagnostic medical devices or are aware of distributors who sell: <strong>\u2019Fin\u0435\u0441\u0430r\u0435TM Fully-Automatic FlA Analyzer\u2019 from manufacturer Guangzhou Wondfo Biotech Co., Ltd., China, on Romanian territory, based on the falsified certificate<\/strong>, 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 \/>\n<strong>The valid certificate held by this manufacturer has the same number and was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), on 2021-08-12 and is valid until 2026-08-11 for the following product categories:<br \/>\nFinecareTM CRP Test W201P0010<br \/>\nFinecareTM CRP Test W201P0011<br \/>\nFinecareTM HbA1c Test W207-C7PM<\/strong><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 \/>\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>30.01.2024 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-11627","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\/11627","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=11627"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11627\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11627"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11627"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11627"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}