EU → US Device Access

HEMODIA SAS

FR-MF-000007191 · France · LABEGE

HEMODIA SAS is registered in the European database on medical devices as a manufacturer, with 361 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa360
Class I1

Most frequent device types declared: CHAMP, TUBULURE DE DIALYSE, CUPULE, TUBULURE DE PERFUSION, TUBULURE D'ARTHROSCOPIE.

Among these devices, 168 are declared sterile, 15 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 entryHemodia SAS (FR) · FDA 9681574
Devices in EUDAMED361
Country of registrationFrance

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