EU → US Device Access

MEDEX

FR-MF-000000414 · France · SAINT PRIEST

MEDEX is registered in the European database on medical devices as a manufacturer, with 43 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa43

Most frequent device types declared: MFSV01, FSDMU210, QIT005, SMD002, FSDSU110.

Among these devices, 39 are declared sterile, 2 active, 3 with a measuring function.

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 entryMEDEX (FR) · FDA 3012261967
Devices in EUDAMED43
Country of registrationFrance

Other manufacturers in France

All France manufacturers →