{"id":11644,"date":"2023-10-30T08:00:10","date_gmt":"2023-10-30T05:00:10","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11644"},"modified":"2026-02-06T12:57:41","modified_gmt":"2026-02-06T09:57:41","slug":"important-notification-30-10-2023","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-30-10-2023\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>30.10.2023<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\nThe NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: <strong>Blood glucose monitoring systems (B12, B12 LAEN, B13, B14, B15, B16, B17, B18, B19) manufactured by Prolinx GmbH, Germany<\/strong>, if they have come into possession of the falsified CE certificate of conformity no. N50569-15-8 which would have been issued by Notified Body mdc medical device certification GmbH, Germany (0483), on 2021-08-18, valid until 2024-07-02 for this manufacturer.<br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>Blood glucose monitoring systems (B12, B12 LAEN, B13, B14, B15, B16, B17, B18, B19) from manufacturer Prolinx GmbH, Germany<\/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 \/>\nFor personal verification, we recommend that interested parties consult the information on the website of Notified Body mdc medical device certification GmbH, Germany (0483), by accessing the link below:<br \/>\n<a href=\"https:\/\/www.mdc-ce.de\/downloads\/mdc-documents\/lists-of-certificates.html\" target=\"_blank\">https:\/\/www.mdc-ce.de\/downloads\/mdc-documents\/lists-of-certificates.html<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>30.10.2023 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-11644","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\/11644","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=11644"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11644\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11644"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11644"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11644"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}