EU → North America Device Access

Mesalvo Freiburg GmbH

DE-MF-000019694 · Germany · Freiburg

Mesalvo Freiburg GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa6

Most frequent device types declared: Zenzy.

Among these devices, 6 are declared active.

Devices declared under this manufacturer

Catalogue references include 2.5X, Release V / 2023.0, Release V / 2023.1, Release V / 2023.2, Release V / 2023.3, Release V / 2024.XX ff..

European nomenclature codes declared: V92.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED6
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 GTIN6
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. Mesalvo Freiburg GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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