EU IVDR Medical Devices from Romania

View 2196 EU IVDR medical devices from Romania on BEUDAMED, the Better Database on Medical Devices. This listing focuses on in vitro diagnostic devices placed on the EU market by Romanian manufacturers and economic operators under the IVDR. Entries include device identification, declared risk class, manufacturer contact details and conformity status to support transparent market information.

Under the IVDR, IVDs are classified from A to D and higher-risk devices require notified body involvement and clinical evidence; BEUDAMED records indicate reported classification and conformity assessment details. Search results help regulators, laboratories and procurement teams verify market status, certificates and post-market vigilance information for Romanian IVDs, with data updated as manufacturers submit required declarations.