EU → US Device Access

MedXpert GmbH

DE-MF-000005489 · Germany · Eschbach

MedXpert GmbH is registered in the European database on medical devices as a manufacturer, with 131 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb70
Class IIa61

Most frequent device types declared: 014-02009 Titan 3D-Rippenklammer, 9 Segmente,XL, 026-00010 Pectus Schraubendreher .

Among these devices, 70 are declared implantable, 43 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 entryMedXpert GmbH (DE) · FDA 3006801247
Devices in EUDAMED131
Country of registrationGermany

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