EU → North America Device Access

Walz Elektronik GmbH

DE-MF-000006132 · Germany · Rohrdorf

Walz Elektronik GmbH is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa9
Class IIb1

Among these devices, 9 are declared sterile, 1 active.

Catalogue references include EL27C230VEHL, P201400FST, P243000FST, P243000SST, P303000FST, P303000SST.

European nomenclature codes declared: Z12020385, Z12020303.

United States market access

FDA establishment registerRegistered with FDA
Matched entryWALZ ELEKTRONIK GMBH (DE) · FDA 1000161819
Devices in EUDAMED10
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN10
Found in the U.S. device database8
Share80.0 %

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

Other manufacturers in Germany

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