EU → US Device Access

EKF-diagnostic GmbH

DE-MF-000006416 · Germany · Barleben

EKF-diagnostic GmbH is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

other17

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 entryEKF DIAGNOSTIC GMBH (DE) · FDA 3004838836
Devices in EUDAMED17
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
V76 044132 0027issued2031-06-23
V76 044132 0026supplemented2030-10-22

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