{"id":11640,"date":"2023-12-13T08:00:34","date_gmt":"2023-12-13T05:00:34","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11640"},"modified":"2026-02-06T12:50:40","modified_gmt":"2026-02-06T09:50:40","slug":"important-notification-13-12-2023","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-13-12-2023\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>13.12.2023<\/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>\u2019Medical Natural Rubber Latex Examination Glove\u2019, \u2018Examination Synthetic Rubber Latex Examination Glove\u2019, \u2018Disposable Synthetic Rubber Latex Surgical Glove\u2019, manufactured by Ace Glove(M) Sdn. Bhd., Malaysia<\/strong>, if they have come into possession of the falsified copy of certificate no. Q5 055729 0012 Rev.01 which would have been issued by Certifying Body T\u00dcV S\u00dcD Product Service GmbH, Germany, in accordance with the requirements of standard EN ISO 13485:2016 \u2013 Quality management systems, QMS regulatory requirements, on 2023-05-01, valid until 2026-04-30, 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>Medical Natural Rubber Latex Examination Glove, Examination Synthetic Rubber Latex Examination Glove, Disposable Synthetic Rubber Latex Surgical Glove from manufacturer Ace Glove(M) Sdn. Bhd., Malaysia<\/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 with the same identification data, namely number, issue and expiry date was issued by Certifying Body T\u00dcV S\u00dcD Product Service GmbH, Germany for manufacturer Top Glove Sdn. Bhd. Malaysia, for:<br \/>\n\u2013 Design and Development, Manufacture and Distribution of:<br \/>\n1. Non-Sterile Natural Rubber Latex Examination Glove<br \/>\n2. Non-Sterile Synthetic Rubber Latex Examination Glove<br \/>\n\u2013 Manufacture and Distribution of:<br \/>\n1. Sterile Synthetic Rubber Latex Surgical Glove.<\/strong><br \/>\nFor personal verification, we recommend that interested parties consult the 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 \/>\nhttps:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank<br \/>\nDatabase of falsified certificates:<br \/>\nhttps:\/\/www.tuvsud.com\/de-de\/dienstleistungen\/produktpruefung-und-produktzertifizierung\/zertifikatsdatenbank\/tuev-sued-pruefzeichen\/liste-gefaelschter-zertifikate<\/p>\n","protected":false},"excerpt":{"rendered":"<p>13.12.2023 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-11640","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\/11640","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=11640"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11640\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11640"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11640"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11640"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}