EU → US Device Access

UNION PLASTIC

FR-MF-000008940 · France · SAINT DIDIER EN VELAY

UNION PLASTIC is registered in the European database on medical devices as a manufacturer, with 716 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa716

Among these devices, 45 are declared sterile, 671 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 entryUNION PLASTIC (FR) · FDA 3002477874
Devices in EUDAMED716
Country of registrationFrance

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