EU → North America Device Access

BIOSIGMA S.P.A.

IT-MF-000030370 · Italy · Cantarana di Cona (VE)

BIOSIGMA S.P.A. is registered in the European database on medical devices as a manufacturer, with 175 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Most frequent device types declared: HISTOLOGY/BIOPSY PRODUCTS.

Devices declared under this manufacturer

Showing 12 of 175 declared devices.

Catalogue references include BSA096, BSI1021, BSM580612D/5RO, BSM581052D/4B, BSTA19, BVS1715.

European nomenclature codes declared: W050301020180, W050301020202, W05030501, W05039099, W050301020102, W0503010203.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryBIOSIGMA SPA (IT) · FDA 3002945499
Devices in EUDAMED175
Country of registrationItaly

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN175
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.

Other manufacturers in Italy

All Italy manufacturers →