EU → North America Device Access

BTS S.p.A.

IT-MF-000041044 · Italy · Garbagnate Milanese

BTS S.p.A. is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa9

Most frequent device types declared: 1.0, 6000, BAIOBIT-C, FREEEMG1000, G-Walk.

Among these devices, 9 are declared active.

Devices declared under this manufacturer

Catalogue references include BAIOBIT, BAIOBITC, BTSNET8, BTSTELEREHAB, FR1BUN, GSN2.

European nomenclature codes declared: N010299, Z12062502, Z120605, Z12062503, Z12062699, Z12062401.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
Country of registrationItaly

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

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. BTS S.p.A. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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