EU → US Device Access

Lothar Medtec GmbH

DE-MF-000007469 · Germany · Würzburg

Lothar Medtec GmbH is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa8

Most frequent device types declared: ALDS Hardware Accessories, ALDS, Treatment Optimiser.

Among these devices, 8 are declared active, 8 with a measuring function.

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 entryLOTHAR MEDTEC GMBH (DE) · FDA 3019585254
Devices in EUDAMED8
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
G15 102194 0006amended2030-07-31

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