EU → North America Device Access

Applimed SA

CH-MF-000046641 · Switzerland · Châtel-St-Denis

Applimed SA is registered in the European database on medical devices as a manufacturer, with 138 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa138

Most frequent device types declared: 1102455, 1202180, 1401219, 1901198, 4901073.

Among these devices, 104 are declared sterile.

Authorised representative in the Union: Dansu A/S.

Catalogue references include 1102455, 1211246, 1422505, 1901198, 4901073, 4909957.

European nomenclature codes declared: A13, V9012, M010199, A06010103, H900802, V9001.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED138
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 GTIN138
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. Applimed SA was not found in either the U.S. or the Canadian register.

Other manufacturers in Switzerland

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