EU → North America Device Access

B&T Spa

IT-MF-000027843 · Italy · Forlì

B&T Spa is registered in the European database on medical devices as a manufacturer, with 8 552 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8 552

Most frequent device types declared: GUA, MAT_TOP, RET.

Catalogue references include CTOPCSEDO0025-C000008817, MELYXXM0425-M000044020, MINCXXD0425-M000051668, MPREXXM0425-M000048521, MVELXXM0025-M000047953, RN380520-R000003143.

European nomenclature codes declared: V080702, V08068099, V08030102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8 552
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 GTIN8 552
Found in the U.S. device database0
Share0.0 %

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. B&T Spa was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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