EU → North America Device Access

Volter s.r.o.

CZ-MF-000041158 · Czechia · Prague

Volter s.r.o. is registered in the European database on medical devices as a manufacturer, with 85 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa85

Most frequent device types declared: Accessories for xRover Reha, ePower, xRover Reha.

Devices declared under this manufacturer

Showing 12 of 85 declared devices.

Catalogue references include 101045, 201026-M, 201030, 202005, 202010, 203001.

European nomenclature codes declared: Y122499, Y122406, Y122103, Y122403, Y122410.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED85
Country of registrationCzechia

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

Device-level evidence

Devices with a numeric GTIN85
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. Volter s.r.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Czechia

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