EU → North America Device Access

Semeda GmbH

DE-MF-000008334 · Germany · Bad Bodenteich

Semeda GmbH is registered in the European database on medical devices as a manufacturer, with 130 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa130

Devices declared under this manufacturer

Showing 12 of 130 declared devices.

Catalogue references include AL 1411-120-L, BE 0600-000, BO 2300-080-R, BO 2300-115-R, CB 1811-090-L, CW 1833-100-L.

European nomenclature codes declared: Y06120601, Y061203, Y061280, Y061299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED130
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 GTIN130
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. Semeda GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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