EU → North America Device Access

KONG S.p.A.

IT-MF-000027905 · Italy · Monte Marenzo

KONG S.p.A. is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa14

Most frequent device types declared: SPINALB, STRETCHERS, VACUUMM.

Devices declared under this manufacturer

Showing 12 of 14 declared devices.

Catalogue references include 855.00, 855.0M, 855.11, 855.12, 855.16, 870.04.

European nomenclature codes declared: V08050199, V080504, V0804.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED14
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 GTIN14
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. KONG S.p.A. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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