EU → North America Device Access

PROMOITALIA GROUP SPA

IT-MF-000030385 · Italy · Milan

PROMOITALIA GROUP SPA is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I21
Class IIa4

Among these devices, 25 are declared sterile, 21 implantable.

Devices declared under this manufacturer

Showing 12 of 25 declared devices.

Catalogue references include 40123V, 40124V, 40125V, 40252, 40273, 40275.

European nomenclature codes declared: P900402, B0501.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED25
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

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. PROMOITALIA GROUP SPA was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

All Italy manufacturers →