EU → North America Device Access

Comde-Derenda GmbH

DE-MF-000026033 · Germany · Stahnsdorf

Comde-Derenda GmbH is registered in the European database on medical devices as a manufacturer, with 59 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa59

Most frequent device types declared: D14KF, D30AB, D35FKB, D35KB, D56Ambu Longlife.

Devices declared under this manufacturer

Showing 12 of 59 declared devices.

Catalogue references include D30AB M8, D35KB zum Einhängen, D56Ambu Longlife M8, KS 115, KS 130, KS 135.

European nomenclature codes declared: Y120303, Y120380.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED59
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 GTIN59
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. Comde-Derenda GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →