EU → North America Device Access

Wizjo Sp. z o.o.

PL-MF-000029048 · Poland · Rzeszów

Wizjo Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa28

Most frequent device types declared: Materac Medyczny.

Devices declared under this manufacturer

Showing 12 of 28 declared devices.

Catalogue references include 25524, 25524C, 25524D, 25526D, PS4847_108209, PS4847_108212.

European nomenclature codes declared: V080702, V0899.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED28
Country of registrationPoland

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

Device-level evidence

Devices with a numeric GTIN28
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. Wizjo Sp. z o.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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