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EUDAMED last updated this device on Mar 24, 2025
590649294ODBKLE2010.5 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by KOLASA SPÓŁKA JAWNA. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05906492940426590649294ODBKLE2010.5(01)05906492940426
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01030199HAEMATOLOGY REAGENTS - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW010No 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-000044993No 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.