20.10.2021
To the attention of all importers and distributors of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type Contrast media injectors 4 connecting tube accessories, manufactured by Shenzhen Seacrown Electromechanical Co., Ltd., China, if they have come into possession of the falsified copy of the CE certificate of conformity no. 4545GB410200806 issued by Notified Body MEDCERT Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH, Germany (0482) on 2020-08-06, valid until 2024-05-27, copy that includes in the annex to the certificate, at the list of products/product categories included in the scope of the certificate, precisely these types of medical devices.
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, please check the NAMMDR website for such information 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.