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EUDAMED last updated this device on Feb 23, 2026
B-08053172972981Direct Bilirubin (DPD) - Biotecnica Systems is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by GIESSE DIAGNOSTICS SRL. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08053172972981B-08053172972981BT0033(01)08053172972981
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01010203BILIRUBIN4 warnings recorded — scroll inside the panel to see all entries.
CW081CW162CW167CW158No certificate specifically references this device's Basic UDI-DI.
Primary placement in Italy; available across 1 country total.
Placed on the market in Italy; per-country availability dates not published.
IT-MF-000039031No 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.