EU → North America Device Access

Rudolf Heintel Gesellschaft m.b.H.

AT-MF-000050568 · Austria · Vienna

Rudolf Heintel Gesellschaft m.b.H. is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa24

Catalogue references include HSOSAFEBELT, HSOSAFIX1000, HSOSAFIX2000, HSOSAFIX5000, HSOTF01, HSOTRFIX4000.

European nomenclature codes declared: V0804, R01058001, M030599, A06030399, R01038099, M040499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED24
Country of registrationAustria

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

Device-level evidence

Devices with a numeric GTIN24
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. Rudolf Heintel Gesellschaft m.b.H. was not found in either the U.S. or the Canadian register.

Other manufacturers in Austria

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