EU → North America Device Access

Gammadis Farmaceutici Srl

IT-MF-000032982 · Italy · CIVITANOVA MARCHE

Gammadis Farmaceutici Srl is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa22

Most frequent device types declared: Benda di garza orlata, Coni auricolari 2 pz, Contenitore Urina 24 H, Cotone idrofilo 50 g, Elettrodo per ECG.

Devices declared under this manufacturer

Showing 12 of 23 declared devices.

Catalogue references include 105103, 107140, 107142, 107143, 107144-107145-107146, 112004.

European nomenclature codes declared: M0304010202, V0812, M9001, M010101, T01010102, M04010101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED23
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 GTIN23
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. Gammadis Farmaceutici Srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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