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PRESTIGE 24i LQ BIL DIRECT

by PZ CORMAY Spółka Akcyjna 2 variants

Ref 4-448Model PRESTIGE 24i LQ BIL DIRECT

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05907514644483 Basic UDI-DI 05907514644483UDI-DIDate17 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Bil Direct
Model / Reference
PRESTIGE 24i LQ BIL DIRECT, 4-448
Primary DI / UDI-DI
05907514644483
Basic UDI-DI
B-05907514644483
EMDN Code
W01010203 Bilirubin
Device Class
Class IVD General
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000023053

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No