EU → North America Device Access

GIESSE DIAGNOSTICS SRL

IT-MF-000039031 · Italy · GUIDONIA MONTECELIO

GIESSE DIAGNOSTICS SRL is registered in the European database on medical devices as a manufacturer, with 198 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: 0026, 0075, 0236, 4194, 5050.

Devices declared under this manufacturer

Showing 12 of 198 declared devices.

Catalogue references include 0075, 0236, 4194, 5050, 6004, 7732.

European nomenclature codes declared: W01010203, W01021109, W0599, W0105011002, W01021110, W01010105.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED198
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 GTIN198
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. GIESSE DIAGNOSTICS SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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