10.06.2021
To the attention of all importers and distributors of medical devices
The National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices manufactured by Surgi Edge, India, bearing the CE marking 2265, for which they have received a CE certificate of conformity which would have been issued by Notified Body 3EC International a.s., Slovakia (2265) for this manufacturer. According to the information made available to us, this manufacturer is not the client of Notified Body 3EC International a.s., Slovakia (2265) and does not own any valid EC certificate of conformity issued by this Body.
To 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.