EU → North America Device Access

Centre Barbara Schardt e.K.

DE-MF-000021441 · Germany · Dietersburg

Centre Barbara Schardt e.K. is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa22

Most frequent device types declared: Bettzügel, Centre Gleithilfen.

Devices declared under this manufacturer

Showing 12 of 22 declared devices.

Catalogue references include 32540 AC, 32540 H, 51110 S, 51120, 51120 SL, 51140.

European nomenclature codes declared: Z12019010, V08068002.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED22
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 GTIN22
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. Centre Barbara Schardt e.K. was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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