EU → North America Device Access

ORINK HUNGARY Kft.

HU-MF-000057489 · Hungary · Budapest

ORINK HUNGARY Kft. is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa10

Most frequent device types declared: Bluering, Bluering PE.

Devices declared under this manufacturer

Catalogue references include B-OL-40x50, B-OL-50x50, B-OL-60x100, B-OL-60x50, B-OL-70x100, B-OL-70x50.

European nomenclature codes declared: T030502.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
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 GTIN10
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. ORINK HUNGARY Kft. was not found in either the U.S. or the Canadian register.

Other manufacturers in Hungary

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