EU → US 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 10ml, oral solution, sachets of 10 ml.

Authorised representative in the Union: IT-AR-000047395.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED34
Country of registrationSwitzerland
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

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

Other manufacturers in Switzerland

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