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Bilirubin total (R)

by Clinichem Ltd. Hungary EUDAMED

Ref 49291

EMDN W01010203

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-49291MF000041060GZ Basic UDI-DIDate4 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
49291
Primary DI / UDI-DI
D-49291MF000041060GZ
Basic UDI-DI
B-49291MF000041060GZ
EMDN Code
W01010203 Bilirubin
Device Class
Class IVD General
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000041060

Other devices from Clinichem Ltd.

See all devices from Clinichem Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED D-49291MF000041060GZ|B-49291MF000041060GZ 61 fields · synced 25 Oct 2026