EU → North America Device Access

HORIZONTE Projects GmbH

DE-MF-000006580 · Germany · Hamburg

HORIZONTE Projects GmbH is registered in the European database on medical devices as a manufacturer, with 46 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa46

Catalogue references include 118HHV05V01, 209HAC01V04, 219HKI01V01, 219HKI02V01, 220HAC33V03, 221HAC39V01.

European nomenclature codes declared: M03040299, M9001, V9099, M0303010201.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED46
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 GTIN46
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. HORIZONTE Projects GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →