EU → US Device Access

IDETEC SAS

FR-MF-000018489 · France · Nimes

IDETEC SAS is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb20

Most frequent device types declared: SD30C FPD+21 , SD30C S12, SD30T P3,5, SD30 DR, SD30 P15.

Among these devices, 20 are declared active.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED20
Country of registrationFrance
⚠️ 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
278/MDRissued2031-04-26

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