{"id":11913,"date":"2021-02-26T09:00:19","date_gmt":"2021-02-26T06:00:19","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11913"},"modified":"2026-03-17T11:58:45","modified_gmt":"2026-03-17T08:58:45","slug":"important-notification-26-02-2021-2","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-26-02-2021-2\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>26.02.2021<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of all importers and distributors of medical devices<\/strong><\/span><br \/>\nThe National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type <strong>Protective Clothing &#038; Equipment, Sterile NaCl-solutions \u2013 Physical acting products for the treatment of gastro-intestinal disorders \u2013 Physical acting products for the treatment of topical applications \u2013 Products for the treatment of dry eyes \u2013 Products for the treatment of vaginal disorders \u2013 Products for alleviation of haemorrhoidal disorders \u2013 Products for the treatment of sore throat, dry cough and hoarseness \u2013 Physically acting products for the application on mucous membranes, manufactured by Medi-Inn GmbH, Germany<\/strong>, if they have received the falsified EC certificate of conformity no. 3558GB414200519, which would be issued for this manufacturer by Notified Body MEDCERT Zertifizierungs- und Pr\u00fcfungsgesellschaft f\u00fcr die Medizin GmbH, Germany (0482), on 2020-05-19, valid until 2024-05-27.<br \/>\nThe rightful holder of the CE certificate of conformity no. 3558GB414200519, issued by Notified Body MEDCERT Zertifizierungs- und Pr\u00fcfungsgesellschaft f\u00fcr die Medizin GmbH, Germany (0482) on 2020-05-19, valid until 2024-05-27, is manufacturer H\u00e4lsa Pharma GmbH, Germany, for medical devices of type <strong>Isotonic NaCl-solutions \u2013 Sterile NaCl-solutions \u2013 Physical acting products for the treatment of gastro-intestinal disorders \u2013 Physical acting products for the treatment of topical applications \u2013 Products for the treatment of dry eyes \u2013 Products for the treatment of vaginal disorders \u2013 Products for alleviation of haemorrhoidal disorders \u2013 Products for the treatment of sore throat, dry cough and hoarseness \u2013 Physically acting products for the application on mucous membranes.<br \/>\nTo prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95\/2006 on healthcare reform, republished, as further amended and supplemented.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>26.02.2021 To the attention of all importers and distributors of medical devices The National Agency for Medicines and Medical Devices [&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-11913","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\/11913","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=11913"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11913\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11913"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11913"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11913"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}