EU → North America Device Access

PSM Medical GmbH

DE-MF-000005468 · Germany · Gunningen

PSM Medical GmbH is registered in the European database on medical devices as a manufacturer, with 241 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb134
Class IIa107

Most frequent device types declared: BENEfit, BENEtube, Beneplate, Beneslider, MENTOPLATE.

Among these devices, 134 are declared sterile, 134 implantable.

Devices declared under this manufacturer

Showing 12 of 241 declared devices.

Catalogue references include 33-64421, ST-33-12309, ST-33-13608, ST-33-21507, ST-33-22013, ST-33-820-07.

European nomenclature codes declared: Q010499.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPSM Medical GmbH (DE) · FDA 3008323540
Devices in EUDAMED241
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN241
Found in the U.S. device database73
Share30.3 %

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. PSM Medical GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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