EU → US Device Access

Compumedics Germany GmbH

DE-MF-000005586 · Germany · Singen

Compumedics Germany GmbH is registered in the European database on medical devices as a manufacturer, with 47 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa47

Most frequent device types declared: Monitoring Probes, Handheld Probes, EZ-Dop Series, Microprobes 16 MHz, Multi-Dop® T.

Among these devices, 47 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 entryCompumedics Germany GmbH (DE) · FDA 3004752776
Devices in EUDAMED47
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
G10 054221 0016issued2028-04-03

Other manufacturers in Germany

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