EU → North America Device Access

Künzli SwissSchuh AG

CH-MF-000044954 · Switzerland · Windisch

Künzli SwissSchuh AG is registered in the European database on medical devices as a manufacturer, with 464 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa464

Most frequent device types declared: Achillesschuhe, Stabilschuhe.

Authorised representative in the Union: Axxos GmbH.

Devices declared under this manufacturer

Showing 12 of 464 declared devices.

Catalogue references include 40145, 40595, 45121, 45125, 45127, 45145.

European nomenclature codes declared: Y063303.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED464
Country of registrationSwitzerland

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

Device-level evidence

Devices with a numeric GTIN464
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. Künzli SwissSchuh AG was not found in either the U.S. or the Canadian register.

Other manufacturers in Switzerland

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