EU → US Device Access

Wytwórnia Sprzętu Rehabilitacyjnego Comfort sp. z o.o.

PL-MF-000004779 · Poland · Poznań

Wytwórnia Sprzętu Rehabilitacyjnego Comfort sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 388 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa388

Most frequent device types declared: [1], [3], [4], [5], [6], [6+], [7], [8], [9] Coala, D1950xS850xW140 plus D200xS850xW200, BSOB 124 .

Among these devices, 1 are declared sterile.

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 EUDAMED388
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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