EU → North America Device Access

Manfred Schägner GmbH

DE-MF-000006001 · Germany · Steinmauern

Manfred Schägner GmbH is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa26

Among these devices, 1 are declared with a measuring function.

Devices declared under this manufacturer

Showing 12 of 26 declared devices.

Catalogue references include 100117, 100208, 101705, 101718, 101905, 102703.

European nomenclature codes declared: A99, V0199, V0380.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED26
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 GTIN26
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. Manfred Schägner GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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