EU → North America Device Access

SCHMITZ medical GmbH

DE-MF-000008189 · Germany · Wickede (Ruhr)

SCHMITZ medical GmbH is registered in the European database on medical devices as a manufacturer, with 506 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa506

Most frequent device types declared: Anteris, DIAMOND, OPX mobilis® RC, STL / STS, UniLeg.

Among these devices, 406 are declared active.

Devices declared under this manufacturer

Showing 12 of 506 declared devices.

Catalogue references include 101.0474.0, 101.0563.0, 101.0595.0, 101.0654.0, 101.0742.0, 101.0762.0.

European nomenclature codes declared: V08020199,Z12011280, Z12011202,Z12011280, V08050101,Z12011280, Z12011202, Z12011280,Z12130202, V08020199.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySCHMITZ medical GmbH (DE) · FDA 3010037894
Devices in EUDAMED506
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN506
Found in the U.S. device database1
Share0.2 %

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. SCHMITZ medical GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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