EU → US Device Access

Zakład Produkcji Pościeli "ŚWIT" Izabela Wintoniak

PL-MF-000043811 · Poland · Zielona Góra

Zakład Produkcji Pościeli "ŚWIT" Izabela Wintoniak is registered in the European database on medical devices as a manufacturer, with 53 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa53

Most frequent device types declared: Odzież chirurgiczna niejałowa – koszula chirurgiczna, Obłożenie chirurgiczne niejałowe – prześcieradło medyczne, Odzież chirurgiczna niejałowa – ubranie chirurgiczne DAMSKIE/MĘSKIE, Obłożenie chirurgiczne niejałowe – poszwa medyczna, Odzież chirurgiczna niejałowa – fartuch chirurgiczny DAMSKI/MĘSKI.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED53
Country of registrationPoland
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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