EU → US Device Access

FIAB S.p.A.

IT-MF-000005988 · Italy · Vicchio

FIAB S.p.A. is registered in the European database on medical devices as a manufacturer, with 2 683 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 732
Class IIb951

Most frequent device types declared: Fully gelled electrodes for neurostimulation, Fastening elastic belts, ECG patient cable - European Version, Disposable sterile pencil for electrosurgery, Sterile disposable electrosurgery electrode.

Among these devices, 530 are declared sterile, 8 reusable, 951 active, 1 with a measuring function.

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 registerNot found in the FDA register
Devices in EUDAMED2 683
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Other manufacturers in Italy

All Italy manufacturers →