EU → North America 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: Adapter cables, Adapter for electrosurgery, Connecting cables between pads and electrosurgical unit, Disposable ECG electrodes with connection cable, Disposable electrode for electrosurgery.

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

Catalogue references include F4046T, F47706VK.25, F7805PW/V, F7830/ADTEKBIO, F7922/2MT, F9053PR/10.

European nomenclature codes declared: C020401, N010299, Z12050380, C020501, C0280, Z12050680.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED2 683
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN2 683
Found in the U.S. device database126
Share4.7 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. FIAB S.p.A. was not found in either the U.S. or the Canadian register.

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