SOFAP Medical
Tunisian dispositifs médicaux exporter
SOFAP Medical is listed in the CEPEX Tunisian exporter directory under Dispositifs médicaux. The official profile identifies the company in Tunis and links the corporate domain used here.
- Type
- Manufacturer
- Location
- Tunis, Tunisia
- Website
- https://sofapmedical.com
- Categories
- Medical & Healthcare Supplies, Pharmaceutical Manufacturing
- Markets
- Tunisia, France, Germany, Italy
Listed in a source registry
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- domain-registered (green), checked 2026-08-09 Domain registry record
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
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)