{"id":11638,"date":"2023-12-14T09:00:50","date_gmt":"2023-12-14T06:00:50","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11638"},"modified":"2026-02-06T12:48:58","modified_gmt":"2026-02-06T09:48:58","slug":"important-notification-14-12-2023-2","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-14-12-2023-2\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>14.12.2023<\/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>\u2019Disposable Latex Surgical Gloves, Disposable Latex Examination Gloves\u2019 manufactured by Pidegree Industrial Co.,Limited., China<\/strong>, if they have come into possession of the falsified copy of the EC certificate of conformity no. G2 074980 0012 Rev. 01 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2020-03-04, valid until 2024-05-26 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>\u2019Disposable Latex Surgical Gloves\u2019, \u2018Disposable Latex Examination Gloves\u2019 from manufacturer Pidegree Industrial Co., Limited., China<\/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, date of issue and expiry and belonging to product category \u2018Disposable Latex Surgical Gloves\u2019, was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123), for manufacturer Tianchang Hengsheng Medical Devices Co.,Ltd., China.<\/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 \/>\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>14.12.2023 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-11638","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\/11638","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=11638"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11638\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11638"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11638"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11638"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}