BIOMET FRANCE
- Type
- Manufacturer
- Location
- Valence Drome, France
- Categories
- Dental Supplies & Equipment
Listed in a source registry
Verified facts
- manufacturing-practice-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- operating-permit (green), checked 2026-08-19 EudraGMDP manufacturing authorisation register (EMA)
- sanctions-clear (green), checked 2026-08-20 OpenSanctions
- debarment-clear (green), checked 2026-08-20 OpenSanctions
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
- gmp-certified (green), checked 2023-09-15 EudraGMDP, EU register of GMP certificates (EMA)
Claimed certifications
- Good Manufacturing Practice
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)