EU → North America Device Access

PROFIMED GmbH

DE-MF-000006873 · Germany · Wasserburg am Inn

PROFIMED GmbH is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa8

Catalogue references include 31201, 31202, 31203, 31211, 31212, 31213.

European nomenclature codes declared: Q010503.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPROFIMED SRL (IT) · FDA 3003603939
Devices in EUDAMED8
Country of registrationGermany

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

Other manufacturers in Germany

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