EU → North America Device Access

Moje Bambino Sp. z o.o.

PL-MF-000018444 · Poland · ŁÓDŹ

Moje Bambino Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 344 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa344

Most frequent device types declared: Kanapka leżaczek, Kanapka trójkątna, Klocki duo, Materac antypoślizgowy, Materac lekki.

Among these devices, 1 are declared active.

Devices declared under this manufacturer

Showing 12 of 344 declared devices.

Catalogue references include 097103-4, 097110-2, 101130N, 101131N, 101837PU, 855693.

European nomenclature codes declared: Y0599, V92.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED344
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 GTIN344
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. Moje Bambino Sp. z o.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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