EU → North America Device Access

R-dental Dentalerzeugnisse GmbH

DE-MF-000010090 · Germany · Hamburg

R-dental Dentalerzeugnisse GmbH is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa33

Catalogue references include MIK1045, MIK1057, MIK1098, MIK1099, MIK2099, MIP1081.

European nomenclature codes declared: Z12110199, Q01020199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED33
Country of registrationGermany

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

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. R-dental Dentalerzeugnisse GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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