EU → North America 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 IIa61
Class IIb70

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.

Devices declared under this manufacturer

Showing 12 of 131 declared devices.

Catalogue references include 010-00020, 010-01540, 012-04226, 014-01013, 014-02006, 015-01420.

European nomenclature codes declared: L091001, P09120299, P09120599, V0402.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMedXpert GmbH (DE) · FDA 3006801247
Devices in EUDAMED131
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN131
Found in the U.S. device database99
Share75.6 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. MedXpert GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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