EU → US Device Access

Novanta Medical GmbH

DE-MF-000005815 · Germany · Berlin

Novanta Medical 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 IIa5

Most frequent device types declared: FZ123, ST254, FZ122.

Among these devices, 1 are declared sterile.

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 entryNovanta Medical GmbH (DE) · FDA 3001556604
Devices in EUDAMED5
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
HZ 1015743-1amended2030-02-04

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