EU → North America Device Access

Unintech GmbH

DE-MF-000005136 · Germany · Düsseldorf

Unintech GmbH is registered in the European database on medical devices as a manufacturer, with 64 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa64

Among these devices, 8 are declared active.

Catalogue references include UNT-CD1080.10, UNT-I-307520E, UNT-I-3365N, UNT-I-8280, UNT-I-861290, UNT-XI-542610K-ESM.

European nomenclature codes declared: S010401, L098099, L0317, A070199, Z12020401, Z12020406.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED64
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 GTIN64
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. Unintech GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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