EU → North America Device Access

provita medical gmbh & co. kg

DE-MF-000005332 · Germany · WERMELSKIRCHEN

provita medical gmbh & co. kg is registered in the European database on medical devices as a manufacturer, with 688 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa688

Among these devices, 8 are declared active.

Devices declared under this manufacturer

Showing 12 of 688 declared devices.

Catalogue references include 211156, 211572, 213109, 228794, 250988, 343118.

European nomenclature codes declared: Z12030380, Z12040180, Y122103, Z12169099, Z12130202, Z12030399.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPROVITA Medical GmbH & Co. KG (DE) · FDA 9614609
Devices in EUDAMED688
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN688
Found in the U.S. device database5
Share0.7 %

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. provita medical gmbh & co. kg is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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