EU → US Device Access

FLUOPTICS SAS

FR-MF-000000403 · France · Grenoble

FLUOPTICS SAS is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa13

Most frequent device types declared: FK-CL.

Among these devices, 6 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 registerRegistered with FDA
Matched entryFLUOPTICS SAS (FR) · FDA 3011092264
Devices in EUDAMED13
Country of registrationFrance

Notified body certificates

CertificateStatusExpiry
DZ 1224696-1amended2027-11-27

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