EU → North America Device Access

KATARZYNA KOTASIŃSKA USŁUGI BRANŻY METALOWEJ

PL-MF-000043708 · Poland · Namysłów

KATARZYNA KOTASIŃSKA USŁUGI BRANŻY METALOWEJ is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa6

Most frequent device types declared: STEL.

Among these devices, 3 are declared active.

Devices declared under this manufacturer

Catalogue references include FoZa Surgi 2, SR-P, SR-S, STEL2B, STEL2BL, STEL3B.

European nomenclature codes declared: V08060199, V080603.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED6
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 GTIN6
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. KATARZYNA KOTASIŃSKA USŁUGI BRANŻY METALOWEJ was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

All Poland manufacturers →