EU → North America Device Access

HASOMED Hard- und Software für Medizin Gesellschaft mbH

DE-MF-000006439 · Germany · Magdeburg

HASOMED Hard- und Software für Medizin Gesellschaft mbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Most frequent device types declared: Reha0099.

Among these devices, 1 are declared active.

Catalogue references include Reha0099, Reha0108, Reha0152, RehaXXXX.

European nomenclature codes declared: Y0599, Y0580.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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 GTIN5
Found in the U.S. device database1
Share20.0 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

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. HASOMED Hard- und Software für Medizin Gesellschaft mbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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