EU → North America Device Access

Vivira Health Lab GmbH

DE-MF-000006530 · Germany · München

Vivira Health Lab GmbH is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: ViViRA.

Among these devices, 8 are declared active.

Devices declared under this manufacturer

Catalogue references include Version 1.x, ViVIRA Android 2.61.x, ViVIRA iOS 2.68.0, ViVIRA iOS 2.69.x, ViViRA Knie Android, ViViRA Knie iOS.

European nomenclature codes declared: Z12069092.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN8
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: Neither register. Vivira Health Lab GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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