EU → North America Device Access

Swissdentacare SA

CH-MF-000016591 · Switzerland · Bioggio

Swissdentacare SA is registered in the European database on medical devices as a manufacturer, with 86 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa86

Authorised representative in the Union: SDC Distribution GmbH.

Catalogue references include 1125-1/3, 1125/3, 1140-1/3, 1300/S4, 1310-1/5, 1600-UF/3.

European nomenclature codes declared: Q01010199,Q010499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED86
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 GTIN86
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. Swissdentacare SA was not found in either the U.S. or the Canadian register.

Other manufacturers in Switzerland

All Switzerland manufacturers →