EU → North America Device Access

UGOFLEX MANUFACTORY SRL

IT-MF-000047522 · Italy · BASSANO DEL GRAPPA

UGOFLEX MANUFACTORY SRL is registered in the European database on medical devices as a manufacturer, with 150 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa150

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Showing 12 of 150 declared devices.

Catalogue references include CARAVAGGIO, FIVE, IMPERIALE 1500 M FISSO, IMPERIALE 3000 M FISSO, MOTIVA ATP, NEXT DREAM PLUS FIRM.

European nomenclature codes declared: V0899, V080399, V080699, V08060199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED150
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 GTIN150
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. UGOFLEX MANUFACTORY SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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