EU → North America Device Access

MULTITEX SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

PL-MF-000048083 · Poland · Głogówek

MULTITEX SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa13

Most frequent device types declared: 15 cm, Materac rehabilitacyjny, SANIvent-GO.

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include TS0211_0233, TS1102_0134, TS1102_0234, TS1102_0434, TS4602_0233, TS4602_0333.

European nomenclature codes declared: V08030102, V080399, V0880, V08068099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED13
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 GTIN13
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. MULTITEX SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

All Poland manufacturers →