Micro-Mega SA
- Type
- brand seeking distribution
- Location
- BESANCON Doubs, France
- Categories
- Tandheelkundige benodigdheden en apparatuur, Medische en gezondheidszorgbenodigdheden
Listed in a source registry
Verified facts
- registered-manufacturer (green), checked 2026-08-22 Agencia Estatal de Medicamentos y Tecnologias en Salud (AGEMED, Bolivia), listado oficial de registros sanitarios aprobados
- places-goods-on-market (green), checked 2026-08-30 Registre national des producteurs (ADEME/SYDEREP), France
- export-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
- debarment-clear (green), checked 2026-08-20 OpenSanctions
- sanctions-clear (green), checked 2026-08-20 OpenSanctions
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
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)