EU → US Device Access

eResearchTechnology GmbH

DE-MF-000008015 · Germany · Estenfeld

eResearchTechnology GmbH is registered in the European database on medical devices as a manufacturer, with 39 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa39

Most frequent device types declared: AM3.

Among these devices, 39 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 entryeResearchTechnology GmbH (DE) · FDA 3008505660
Devices in EUDAMED39
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
G10 084128 0024issued2027-07-31

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