BIOVANTIC PHARMA MEDICAL DEVICES LIMITED

Listed in a source registry

French national producer register (ADEME/SYDEREP)

Verified facts

• registry-id-verified (green), checked 2026-08-02 Companies House
• places-goods-on-market (green), checked 2026-08-09 Registre national des producteurs (ADEME/SYDEREP), France

Import rules for these goods

• Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
• For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
• Medicines imported into the EU must come from a site holding an EU GMP certificate, and the importer needs a manufacturing/import authorisation. European Medicines Agency (GMP)

Check independently

• Sanctions and watchlists (OpenSanctions)