EU → North America Device Access

"KAPS" SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

PL-MF-000032129 · Poland · Rzezawa

"KAPS" SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 47 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa47

Most frequent device types declared: rozmiary 21-42, rozmiary 36-46.

Devices declared under this manufacturer

Showing 12 of 47 declared devices.

Catalogue references include 103_5001, 103_5002, 103_5004, 103_5005.

European nomenclature codes declared: Y061203.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED47
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 GTIN47
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. "KAPS" SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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