EU → North America Device Access

Intigena (Schweiz) AG

CH-MF-000019385 · Switzerland · Zug

Intigena (Schweiz) AG is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa11

Authorised representative in the Union: Intigena GmbH & Co. KG.

Devices declared under this manufacturer

Catalogue references include 07612621000074, 07612621000081, 07612621000098, 07612621000128, 07612621000142, 07612621000159.

European nomenclature codes declared: T99, T04010199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
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 GTIN11
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. Intigena (Schweiz) AG was not found in either the U.S. or the Canadian register.

Other manufacturers in Switzerland

All Switzerland manufacturers →