EU → North America Device Access

Rolko Kohlgrüber GmbH

DE-MF-000005748 · Germany · Borgholzhausen

Rolko Kohlgrüber GmbH is registered in the European database on medical devices as a manufacturer, with 147 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa147

Most frequent device types declared: Aluminiumrampe, Antidekubitus-Sitzkissen, Drehteller, Rutschbrett, SGE.

Devices declared under this manufacturer

Showing 12 of 147 declared devices.

Catalogue references include DRT-400, HA-KO-ALU-R, MT-IN-V22/25, PU-AK-M, SHG-KS-GB40-KS, SK-COVER-450x450x80-I-S.

European nomenclature codes declared: Y122499, Y122406, V08068099, Y122403, Y1899, Y181899.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryROLKO KOHLGRUBER GMBH (DE) · FDA 1000406324
Devices in EUDAMED147
Country of registrationGermany

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN147
Found in the U.S. device database1
Share0.7 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

Other manufacturers in Germany

All Germany manufacturers →