EU → US Device Access

Novoxel GmbH

DE-MF-000012740 · Germany · Berlin

Novoxel GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6

Most frequent device types declared: MPH00001, MSTX0002, THLM0002, TXLD0012, TPH00001.

Among these devices, 6 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 entryNOVOXEL LTD. (IL) · FDA 3014193078
Devices in EUDAMED6
Country of registrationGermany

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