{"id":11569,"date":"2025-06-18T08:00:06","date_gmt":"2025-06-18T05:00:06","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11569"},"modified":"2026-01-30T10:30:08","modified_gmt":"2026-01-30T07:30:08","slug":"important-notification-18-06-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-18-06-2025\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>18.06.2025<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers, distributors and users of medical devices<\/strong><\/span><br \/>\n18.06.2025<br \/>\nTo the attention of all importers, distributors and users of medical devices<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>\u2018Pulse Oximeter, SPO2 Sensor, Patient Monitor\u2019<\/strong> accompanied by a falsified copy of CE certificate of conformity no. G1 087056 0005 Rev. 02, which would have been issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2024-05-15 and valid until 2028-12-31.<br \/>\n<strong>The valid CE certificate of conformity with no. G1 087056 0005 Rev. 02 was issued by Notified Body T\u00dcV S\u00dcD Product Service GmbH (0123) on 2019-05-16, valid until 2024-05-15, for \u2018SPO2 Monitor, Pulse Oximeter, Spo2 Sensor, Patient Monitor\u2019 and belongs to manufacturer Shanghai Berry Electronic Tech Co., Ltd., China.<\/strong><br \/>\nIf you have come into possession of such medical devices or are aware of distributors who sell <strong>\u2018Pulse Oximeter, SPO2 Sensor, Patient Monitor\u2019<\/strong> on the Romanian territory based on the falsified copy of CE certificate of conformity no. G1 087056 0005 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>18.06.2025 To the attention of all importers, distributors and users of medical devices 18.06.2025 To the attention of all importers, [&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-11569","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\/11569","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=11569"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11569\/revisions"}],"predecessor-version":[{"id":11574,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11569\/revisions\/11574"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11569"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11569"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11569"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}