EU → North America Device Access

PROMED SRL

IT-MF-000031903 · Italy · Villanova di Castenaso

PROMED SRL is registered in the European database on medical devices as a manufacturer, with 36 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa36

Most frequent device types declared: DENTAL UNIT, Dental Unit, Dental patient chair, Riunito Odontoiatrico.

Among these devices, 36 are declared active.

Devices declared under this manufacturer

Showing 12 of 36 declared devices.

Catalogue references include AG03 412E, AG04 412, AG04 B, AG04 E, AG04 EA1, AG04 EA2P.

European nomenclature codes declared: V08020199, Z12110101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED36
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 GTIN36
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. PROMED SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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