EU → North America Device Access

REH4MAT Spółka z ograniczoną odpowiedzialnością

PL-MF-000009271 · Poland · Rzeszów

REH4MAT Spółka z ograniczoną odpowiedzialnością is registered in the European database on medical devices as a manufacturer, with 199 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa199

Most frequent device types declared: 4ARMY-KOL-02, OKD-39, OKD-43, OKG-02, OKG-06.

Devices declared under this manufacturer

Showing 12 of 199 declared devices.

Catalogue references include 4ARMY-KOL-02 10/L, OKD-39 M, OKG-02, OKG-09, OKG-15 L/XL, OKG-31 S.

European nomenclature codes declared: Y061209, Y061203, Y060312, Y060630, Y060606, Y060618.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED199
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 GTIN199
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. REH4MAT Spółka z ograniczoną odpowiedzialnością was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

All Poland manufacturers →