EU → US Device Access

DIXI Medical

FR-MF-000005237 · France · MARCHAUX-CHAUDEFONTAINE

DIXI Medical is registered in the European database on medical devices as a manufacturer, with 80 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa55
Class I25

Most frequent device types declared: Connection cable, Cortical electrode, Microdeep Depth Electrode, Instrument guide, Screwdriers and Wrench for Guiding Screw.

Among these devices, 26 are declared sterile, 1 reusable, 11 active, 2 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 entryDIXI MEDICAL (FR) · FDA 3007636029
Devices in EUDAMED80
Country of registrationFrance

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