EU → North America Device Access

UNIVET SRL

IT-MF-000030077 · Italy · Bergamo

UNIVET SRL is registered in the European database on medical devices as a manufacturer, with 663 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa663

Most frequent device types declared: 536.07, 536.08, 539, 572, 573.

Catalogue references include 53607P098, 539C01397, 582A00093, 584B00293, 584C00196, 584M00197.

European nomenclature codes declared: Q0299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED663
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 GTIN663
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. UNIVET SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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