EU → North America Device Access

Pandhora S.r.l.

IT-MF-000021648 · Italy · Napoli

Pandhora S.r.l. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: MANUAL WHEELCHAIR, Manual wheelchair, Unita' di propulsione elettrica.

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Catalogue references include EP3 ENDURO, EP3 OFF-ROAD, EP3 PLUS, EP3 SMART, EP3 STANDARD, PEVO DOUBLE.

European nomenclature codes declared: Y122410, Y122106.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
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 GTIN8
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. Pandhora S.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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