EU → North America Device Access

4FIZJO GROUP SP. Z O. O.

PL-MF-000031702 · Poland · KONOTOPA

4FIZJO GROUP SP. Z O. O. is registered in the European database on medical devices as a manufacturer, with 196 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa196

Most frequent device types declared: Orteza, Piłeczka do masażu punktowego, Piłka rehabilitacyjna, Poduszka Ortopedyczna, Poduszka ortopedyczna między nogi.

Devices declared under this manufacturer

Showing 12 of 196 declared devices.

Catalogue references include P-5905973407205, P-5905973407397, P-5907222931264, P-5907222931301, P-5907222931950, P-5907739316264.

European nomenclature codes declared: Z120602, Y061209, Y06120601, Y060308, Z120621, Z120603.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED196
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 GTIN196
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. 4FIZJO GROUP SP. Z O. O. was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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