EU → North America Device Access

caresyntax GmbH

DE-MF-000006861 · Germany · Heinsdorfergrund

caresyntax GmbH is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: Medical MultiConsole, Technical Console, Vesa Box.

Among these devices, 6 are declared active.

Devices declared under this manufacturer

Catalogue references include BG000166-BG000171, BG000172-BG000177, BG000391, BG000392, BG000412, BG000413, SW000XXX, SW000YYY.

European nomenclature codes declared: V9099, V92.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
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 GTIN8
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. caresyntax GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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