EU → North America Device Access

GENIMPEX Srl

IT-MF-000038771 · Italy · Brugherio

GENIMPEX Srl is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa12

Devices declared under this manufacturer

Catalogue references include DK-1245-B, DK-1245-T, DK-1245-V, DK-1260-B, DK-1260-V, DK-1290-V.

European nomenclature codes declared: T030501.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED12
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 GTIN12
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. GENIMPEX Srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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