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ZAKŁAD URZĄDZEŃ MEDYCZNYCH UNIMED INŻ. ADAM ANDRUSZCZAK

PL-MF-000008657 · Poland · BYDGOSZCZ

ZAKŁAD URZĄDZEŃ MEDYCZNYCH UNIMED INŻ. ADAM ANDRUSZCZAK is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb7

Most frequent device types declared: IR-10, IR-10MB, IR-10MBF, SRN-10, SRN-10/SFT.

Among these devices, 7 are declared active.

Devices declared under this manufacturer

Catalogue references include IR-10, IR-10MB, IR-10MBF, SRN-10, SRN-10/SFT, SRN-10M.

European nomenclature codes declared: Z1208040302, Z12080407.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
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 GTIN7
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. ZAKŁAD URZĄDZEŃ MEDYCZNYCH UNIMED INŻ. ADAM ANDRUSZCZAK was not found in either the U.S. or the Canadian register.

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