EU → US Device Access

PRIMA Lab SA

CH-MF-000034473 · Switzerland · Morbio Inferiore

PRIMA Lab SA is registered in the European database on medical devices as a manufacturer, with 45 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other45

Most frequent device types declared: HGEH88000KIT01IT, 800060-x, 800034-x, 100077-x, 800017-x.

Authorised representative in the Union: BE-AR-000000040.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED45
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
D1408400113supplemented2028-10-25

Other manufacturers in Switzerland

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