EU → US Device Access

ab medica spa

IT-MF-000029717 · Italy · Milano

ab medica spa is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6

Among these devices, 3 are declared sterile.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerRegistered with FDA
Matched entryAB MEDICA SAS (FR) · FDA 3011221476
Devices in EUDAMED6
Country of registrationItaly

Notified body certificates

CertificateStatusExpiry
0425-MDR-030088-00issued2029-07-30

Other manufacturers in Italy

All Italy manufacturers →