EU → North America Device Access

RESMED Jolanta Sosna

PL-MF-000004329 · Poland · Zabrze

RESMED Jolanta Sosna is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa21

Devices declared under this manufacturer

Showing 12 of 21 declared devices.

Catalogue references include ---.

European nomenclature codes declared: V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED21
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 GTIN21
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. RESMED Jolanta Sosna was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

All Poland manufacturers →