EU → US Device Access

LivaNova Deutschland GmbH

DE-MF-000014243 · Germany · München

LivaNova Deutschland GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa4
Class IIb1

Most frequent device types declared: Perfusion data management system, 75306, Heater Cooler System Stockert 3T, 75220.

Among these devices, 5 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 entryLivaNova Deutschland GmbH (DE) · FDA 9611109
Devices in EUDAMED5
Country of registrationGermany

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