EU → North America Device Access

Uniprox GmbH & Co.KG

DE-MF-000010327 · Germany · Zeulenroda-Triebes

Uniprox GmbH & Co.KG is registered in the European database on medical devices as a manufacturer, with 813 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa813

Catalogue references include 41.160.100.000.032, 41.430.100.000.250, 41.640.304.000.340, 41.680.103.000.210, 41.680.103.050.420, 46.031.800.202.026.

European nomenclature codes declared: Y062409, Y062409,Y062412,Y062415, Y060606, Y062403, Y062409,Y062412, Y062415.

United States market access

FDA establishment registerRegistered with FDA
Matched entryUNIPROX GMBH & CO. KG (DE) · FDA 3008564931
Devices in EUDAMED813
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN813
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: United States only. Uniprox GmbH & Co.KG is registered in the United States but was not found in the Canadian register.

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