Skip to content

BioDye-4DS-eco SYS WBC-5-diff fluorescent dye 3x42mL

by Bioxol Kft EUDAMED

Active European Union

Ref SY-8029Model BioDye-4DS SYS-eco

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5999862176BDye4DSecoSYSQE Basic UDI-DIDate5 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
BioDye-4DS SYS-eco, SY-8029
Primary DI / UDI-DI
05999862176747
Basic UDI-DI
5999862176BDye4DSecoSYSQE
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
Device Class
Class A
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000025409

Other devices from Bioxol Kft

See all devices from Bioxol Kft →

Properties

Show properties
  • Reagent
  • Professional Testing
  • New Device
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