EU → North America Device Access

Meccanica GM s.r.l.

IT-MF-000028992 · Italy · Loreto

Meccanica GM s.r.l. is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: Prodotto Zero, Prodotto Zero PUSH.

Devices declared under this manufacturer

Showing 12 of 18 declared devices.

Catalogue references include 02001.02, 04501, 06001, 06011, 15011, 50002.

European nomenclature codes declared: W05020199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED18
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 GTIN18
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. Meccanica GM s.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

All Italy manufacturers →