EU → North America Device Access

Wieth Medical Systems e.K.

DE-MF-000019163 · Germany · Klein Nordende

Wieth Medical Systems e.K. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa6

Among these devices, 6 are declared active.

Devices declared under this manufacturer

Catalogue references include 0110101, 10073, 10102, 1012.01, 1013.01, 10232.

European nomenclature codes declared: Z12010702, Z129004.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED6
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 GTIN6
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. Wieth Medical Systems e.K. was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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