EU → North America Device Access

SOFAR SWISS SA

CH-MF-000047475 · Switzerland · Lugano

SOFAR SWISS SA is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I34

Most frequent device types declared: MELT IN MOUTH TABLETS, Oral solution, sachets of 10ml, oral solution, sachets of 10 ml, oral solution, sachets of 10ml.

Authorised representative in the Union: ALFASIGMA S.P.A..

Devices declared under this manufacturer

Showing 12 of 34 declared devices.

Catalogue references include ES-C04L, EXX-C04L, EXX-C20L, GF-C04L, GF-C20L, GFD-C20L.

European nomenclature codes declared: G99.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED34
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 GTIN34
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. SOFAR SWISS SA was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
CVD0045250125supplemented2030-04-23
CVD0043250725supplemented2030-04-23
CSQ0028250925supplemented2030-04-23

Other manufacturers in Switzerland

All Switzerland manufacturers →