EU → North America Device Access

SteelBo Sp.z o.o.

PL-MF-000037622 · Poland · Wałbrzych

SteelBo Sp.z o.o. is registered in the European database on medical devices as a manufacturer, with 154 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa154

Devices declared under this manufacturer

Showing 12 of 154 declared devices.

Catalogue references include AB-3CR(SS), AKZ-1 (SS), APSC-1 (TI), APW-1 (TI), AR-1 400 (SS), SBM-1 (AL).

European nomenclature codes declared: Y062499, Y062412, Y062418.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED154
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 GTIN154
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. SteelBo Sp.z o.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

All Poland manufacturers →