EU → North America Device Access

PATELLA-96 Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság

HU-MF-000004588 · Hungary · Törökbálint

PATELLA-96 Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság is registered in the European database on medical devices as a manufacturer, with 385 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa385

Devices declared under this manufacturer

Showing 12 of 385 declared devices.

Catalogue references include GM 4200 Kerekesszék (adapterrel 46), GM 4300 Alu kerekesszék (adapter és kivehető kerék 50), GM-B7 S, GM-C4 M, GM-C6 L, GM-K2 S.

European nomenclature codes declared: Y061203, Y061209, Y060606, Y122106, Y060308, Y06120602.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED385
Country of registrationHungary

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

Device-level evidence

Devices with a numeric GTIN385
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. PATELLA-96 Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság was not found in either the U.S. or the Canadian register.

Other manufacturers in Hungary

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