EU → US Device Access

ELCON Medical Instruments GmbH

DE-MF-000005908 · Germany · Tuttlingen

ELCON Medical Instruments GmbH is registered in the European database on medical devices as a manufacturer, with 11 268 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa11 268

Among these devices, 11 268 are declared reusable.

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 entryELCON MEDICAL INSTRUMENTS GMBH (DE) · FDA 8043816
Devices in EUDAMED11 268
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
D1068800008supplemented2029-10-16

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