EU → North America Device Access

FRELU GmbH

DE-MF-000042760 · Germany · Much

FRELU GmbH is registered in the European database on medical devices as a manufacturer, with 58 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa58

Devices declared under this manufacturer

Showing 12 of 58 declared devices.

Catalogue references include HG1100F, HG2000G, HG2000VG, HG450F, HG450VF, HG700F.

European nomenclature codes declared: Y181803, Y093303.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED58
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

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. FRELU GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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