EU → North America Device Access

Gruppo Industriale Formenti S.a.s.

IT-MF-000050869 · Italy · Bovisio Masciago

Gruppo Industriale Formenti S.a.s. is registered in the European database on medical devices as a manufacturer, with 237 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa237

Most frequent device types declared: GUANCIALI, MATERASSI.

Devices declared under this manufacturer

Showing 12 of 237 declared devices.

Catalogue references include ALFSA, CEMCR, COFAV, COMQS, ECOLF, OMNIE.

European nomenclature codes declared: V080702, V08030102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED237
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 GTIN237
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. Gruppo Industriale Formenti S.a.s. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

All Italy manufacturers →