EU → North America Device Access

Bürki inno med AG

CH-MF-000017443 · Switzerland · Widnau

Bürki inno med AG is registered in the European database on medical devices as a manufacturer, with 78 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa78

Among these devices, 78 are declared reusable.

Authorised representative in the Union: Bürki inno med GmbH.

Devices declared under this manufacturer

Showing 12 of 78 declared devices.

Catalogue references include BA 105/T, BI 128/T, BI 140/T, BI 228/A, BI 229/A, SL 119 a12.

European nomenclature codes declared: Q0299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED78
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 GTIN78
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. Bürki inno med AG was not found in either the U.S. or the Canadian register.

Other manufacturers in Switzerland

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