EU → North America Device Access

"BISK" SPÓŁKA AKCYJNA

PL-MF-000052524 · Poland · Baniocha

"BISK" SPÓŁKA AKCYJNA is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa23

Most frequent device types declared: DUO PRO, PRO, TRIO PRO.

Devices declared under this manufacturer

Showing 12 of 23 declared devices.

Catalogue references include 04781, 04783, 04785, 04786, 04787, 05499.

European nomenclature codes declared: Y181803, Y093303, Y093399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED23
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 GTIN23
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. "BISK" SPÓŁKA AKCYJNA was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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