EU → North America Device Access

O.C. Hairsystems GmbH

DE-MF-000050963 · Germany · Düsseldorf

O.C. Hairsystems GmbH is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa28

Most frequent device types declared: Medical Wig & Medical Hairpiece.

Devices declared under this manufacturer

Showing 12 of 28 declared devices.

Catalogue references include O.C./IFU.

European nomenclature codes declared: Y0699.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED28
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 GTIN28
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. O.C. Hairsystems GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →