EU → North America Device Access

ARMEDICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

PL-MF-000036062 · Poland · DĄBROWA GÓRNICZA

ARMEDICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 512 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa512

Most frequent device types declared: Akcesoria łazienkowe dla osób z ograniczeniami ruchowymi, Balkoniki i podpórki rehabilitacyjne, Kołnierz ortopedyczny, Kule łokciowe i laski inwalidzkie, Orteza.

Among these devices, 2 are declared active.

Devices declared under this manufacturer

Showing 12 of 512 declared devices.

Catalogue references include AR-004, AR-010M, AR-091, AR-2181, AR-222, AR-2260.

European nomenclature codes declared: Y06120601, Y122103, Y061209, Y060308, Y060603, V080399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED512
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 GTIN512
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. ARMEDICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

All Poland manufacturers →