EU → North America Device Access

Schein Orthopädie Service KG

DE-MF-000004958 · Germany · Remscheid

Schein Orthopädie Service KG is registered in the European database on medical devices as a manufacturer, with 60 727 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa60 727

Catalogue references include 0477210000041, 2133320000042, 3443060010034, 3463270000029, 3536020050032, 3725000020036.

European nomenclature codes declared: Y063303.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED60 727
Country of registrationGermany

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

Device-level evidence

Devices with a numeric GTIN60 727
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. Schein Orthopädie Service KG was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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