EU → US Device Access

SOPHiA GENETICS SA

CH-MF-000025221 · Switzerland · Rolle

SOPHiA GENETICS SA is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other17

Authorised representative in the Union: FR-AR-000022214.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED17
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.

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