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Bilirubin total and direct (R)

by Clinichem Ltd. EUDAMED

Active European Union

Ref 49043

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-49043MF000041060A8 Basic UDI-DIDate7 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
49043
Primary DI / UDI-DI
D-49043MF000041060A8
Basic UDI-DI
B-49043MF000041060A8
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

Show 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