EU → North America Device Access

Wagner & Guder Medical GmbH

DE-MF-000009554 · Germany · Bad Sulza

Wagner & Guder Medical GmbH is registered in the European database on medical devices as a manufacturer, with 48 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa48

Most frequent device types declared: Instrumententisch, Ophthalmoskopie-Leuchte CR, Patientenstuhl, Refraktionseinheit.

Among these devices, 48 are declared active.

Devices declared under this manufacturer

Showing 12 of 48 declared devices.

Catalogue references include HT-220, OT-A5, OT-R1, ST-2000, ST-500, TOPLINE.

European nomenclature codes declared: Z12129001.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED48
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN48
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: Neither register. Wagner & Guder Medical GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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