EU → North America Device Access

Andanza GmbH

DE-MF-000049142 · Germany · Meinhard

Andanza GmbH is registered in the European database on medical devices as a manufacturer, with 112 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa112

Devices declared under this manufacturer

Showing 12 of 112 declared devices.

Catalogue references include B1067E, DV1010R, DV1030L, DV1032L XL, DV1041, DV1085T.

European nomenclature codes declared: M030499, M030402010101, M9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED112
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 GTIN112
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. Andanza GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →