EU → US Device Access

NEOMEDLIGHT

FR-MF-000004044 · France · Villeurbanne

NEOMEDLIGHT is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa14

Most frequent device types declared: BCC121, CM211, CM201, CM301, BCC211.

Among these devices, 4 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 entryNEOMEDLIGHT (FR) · FDA 3013919653
Devices in EUDAMED14
Country of registrationFrance

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