EU → US Device Access

LEMER PAX

FR-MF-000003579 · France · Carquefou

LEMER PAX is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa20
Class IIb3

Most frequent device types declared: Equipement amagnétique, Syringe shield, Sterile kit Cathkit, Injector, Dose calibrator.

Among these devices, 4 are declared sterile, 5 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 entryLEMER-PAX (FR) · FDA 3003808764
Devices in EUDAMED23
Country of registrationFrance

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