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

Among these devices, 1 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 388 declared devices.

Catalogue references include MM-W5-SK6-RŁ-PS-OS-Z12, MM-W6-ST4-RŁ-PS-OS-Z16, MX-W6-ST4-RS-PP-OS-Z04, MX-W8-SK6-RS-PS-OL-ZP04, W4-SK6-RŁ-PS-OS-ZP09/MXO, W6-ST4-RŁ-PP-OL-Z04/MMO.

European nomenclature codes declared: Y122103, V080702, V08068099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED388
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 GTIN388
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. Wytwórnia Sprzętu Rehabilitacyjnego Comfort sp. z o.o. was not found in either the U.S. or the Canadian register.

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