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EUDAMED last updated this device on Oct 3, 2025
B-128EN-46N128EN-4 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by GLOBAL PHARMA CM S.A. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-128EN-46NB-128EN-46N128EN-4D-128EN-46N
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q030199NASOPHARYNGEAL DEVICES - OTHERNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Poland; available across 1 country total.
Placed on the market in Poland; per-country availability dates not published.
PL-MF-000034662No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.AC090 MD/2136/5302/2021