{"id":11636,"date":"2023-12-14T08:00:14","date_gmt":"2023-12-14T05:00:14","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11636"},"modified":"2026-02-06T12:47:21","modified_gmt":"2026-02-06T09:47:21","slug":"important-notification-14-12-2023","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-14-12-2023\/","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>\u2019Dental Suction Systems\u2019 manufactured by Suzhou Junwei Medical Equipment Co., Ltd., China<\/strong>, if they have come into possession of the falsified EC certificate of conformity no. G2 18 04 82113 008 which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH, Germany (0123) on 2023-05-25, valid until 2025-05-24, 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>Dental Suction Systems from manufacturer Suzhou Junwei Medical Equipment Co., Ltd., China, 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>Atragem aten\u021bia p\u0103r\u021bilor interesate c\u0103, potrivit informa\u021biilor intrate \u00een posesia ANMDMR, \u00een afara certificatului falsificat mai sus men\u021bionat, pentru acest produc\u0103tor mai exist\u0103 pe pia\u021ba UE \u0219i certificatul falsificat nr. Q8 082551 0003 Rev. 01 which would have been issued by Certifying Body T\u00dcV S\u00dcD Product Service GmbH, Germany on 2022-04-25, valid until 2025-04-24 in accordance with the requirements of standard EN ISO 13485:2016 \u2013 Quality management systems. Requirements for regulatory purposes for Design and Development, Production and Distribution of Medical Oil Free Air Compressors, Dental Suction Systems.<\/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-11636","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\/11636","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=11636"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11636\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11636"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11636"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11636"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}