EU → North America Device Access

Mytronic GmbH

DE-MF-000013849 · Germany · Weilrod

Mytronic GmbH is registered in the European database on medical devices as a manufacturer, with 161 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa161

Among these devices, 154 are declared active.

Devices declared under this manufacturer

Showing 12 of 161 declared devices.

Catalogue references include 130.794.1042.05.781, 130.794.1062.05.762.HE, 407.794.B54.1350.05.21.98.781, 794.B01.1800.05.21.98.762, 795.200.21, 797.300.33.

European nomenclature codes declared: Q01010199, Q01010399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED161
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. Mytronic GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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