EU → North America Device Access

Bismed Michał Stańczyk

PL-MF-000010545 · Poland · Baniocha

Bismed Michał Stańczyk is registered in the European database on medical devices as a manufacturer, with 58 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa58

Most frequent device types declared: 210x80, XC, XK4020.

Devices declared under this manufacturer

Showing 12 of 58 declared devices.

Catalogue references include X14008062L, XC1Z, XC3BCC100, XC3ZP, XK4013B, XK4027.

European nomenclature codes declared: T020401,T0299, T0207, T0299, T04010203,T04010299, T04010299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED58
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 GTIN58
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. Bismed Michał Stańczyk was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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