Skip to content

i-Tracker Ustekinumab

by Biosynex France EUDAMED

Ref CTU 002-50Model i-Tracker Ustekinumab EMDN W0102080799

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number353267CTU002BXB Basic UDI-DIDate21 Apr 2026RegisteredStatusActive

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  • Withdrawn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 · synced 22 Oct 2026

Model / Reference
i-Tracker Ustekinumab, CTU 002-50
Primary DI / UDI-DI
03532672001964
Basic UDI-DI
353267CTU002BXB
EMDN Code
W0102080799 Autoimmune disease tdm - other
Device Class
Class B
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000042615

Other devices from Biosynex

See all devices from Biosynex →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED fdd3c276-03bd-44de-be56-1d2261a5041b 61 fields · synced 22 Oct 2026