EU → North America Device Access

DIETZ GmbH

DE-MF-000009121 · Germany · Karlsbad

DIETZ GmbH is registered in the European database on medical devices as a manufacturer, with 167 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa167

Most frequent device types declared: XXL Rollator.

Devices declared under this manufacturer

Showing 12 of 167 declared devices.

Catalogue references include 109042, 110139, 200107, 200330, 220145, 430105.

European nomenclature codes declared: Y122103, Y120609, Y093303, Y091203, Y091215, V08050303.

United States market access

FDA establishment registerRegistered with FDA
Matched entryDIETZ GMBH (DE) · FDA 3006440543
Devices in EUDAMED167
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN167
Found in the U.S. device database0
Share0.0 %

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

Other manufacturers in Germany

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