EU → North America Device Access

Helmut Hund GmbH

DE-MF-000006335 · Germany · Wetzlar

Helmut Hund GmbH is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: Incident-light fluorescence illuminator for H 600, Incident-light fluorescence illuminator for medicus pro, LED-Auflichtfluoreszenzilluminator, Laboratory Microscope H 600, Laboratory Microscopy.

Devices declared under this manufacturer

Showing 12 of 34 declared devices.

Catalogue references include 008.0370.0, 008.0461.0, 008.0471.0, 008.0472.0, HT3523, HT3540.

European nomenclature codes declared: W0299, Z12029080, W02039099, W0503030199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED34
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 GTIN34
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. Helmut Hund GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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