MEDICA MEDITERRANEE
- Type
- Manufacturer
- Location
- Menzel Jemil Bizerte, Tunisia
- Categories
- Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- industrial-site-registered (green), checked 2026-08-19 APII (Agence de Promotion de l'Industrie et de l'Innovation, Tunisia), directory of operational industrial enterprises
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
- public-subsidy-received (green), checked 2026-08-19 Programme de Mise à Niveau (PMN), entreprises partenaires (data.gov.tn, official open dataset)
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)