{"id":11575,"date":"2025-06-19T08:00:42","date_gmt":"2025-06-19T05:00:42","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11575"},"modified":"2026-01-30T10:33:57","modified_gmt":"2026-01-30T07:33:57","slug":"important-notification-19-06-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-19-06-2025\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>19.06.2025<\/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 medical devices of type <strong>\u2018Infusion Sets for Single Use (with Needle), Sterile Hypodermic Syringes for Single Use (with Needle), Disposable Sterile Hypodermic Needles, Scalp vein Sets, Sterile Insulin Syringes for Single Use, Disposable Transfusion Set (with Needle), Urine Collection Bags\u2019<\/strong> accompanied by the falsified CE certificate no. Q6 073425 0011 Rev. 02, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2022-09-06 and valid until 2025-09-05.<br \/>\n<strong>The valid certificate with the same identification data, namely number, product categories, issue and expiry date belongs to manufacturer Jiangsu Zhengkang Medical Apparatus Co., Ltd., China and was issued by Certifying Body T\u00dcV S\u00dcD Product Service GmbH, Germany in accordance with the requirements of standard EN ISO 13485:2016 \u2013 Medical devices \u2014 Quality management systems \u2014 Requirements for regulatory purposes for \u2018Production and Distribution of Infusion Sets for Single Use (with Needle), Sterile Hypodermic Syringes for Single Use (with Needle), Disposable Sterile Hypodermic Needles, Scalp vein Sets, Sterile Insulin Syringes for Single Use, Disposable Transfusion Set (with Needle), Urine Collection Bags\u2019.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory <strong>\u2018Infusion Sets for Single Use (with Needle), Sterile Hypodermic Syringes for Single Use (with Needle), Disposable Sterile Hypodermic Needles, Scalp vein Sets, Sterile Insulin Syringes for Single Use, Disposable Transfusion Set (with Needle), Urine Collection Bags\u2019<\/strong> based on the falsified copy of certificate no. Q6 073425 0011 Rev. 02, do not use them and notify the National Agency for Medicines and Medical Devices of Romania &#8211; the Market Surveillance Service using the contact details posted on the NAMMDR website.<br \/>\nFor your own 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>19.06.2025 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-11575","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\/11575","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=11575"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11575\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11575"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11575"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11575"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}