Skip to content

i-Tracker Ocrelizumab

by Biosynex France EUDAMED

Ref CTO 002-50Model i-Tracker Ocrelizumab EMDN W0102080799

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number353267CTO002AV7 Basic UDI-DIDate22 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  • Withdrawn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 Ocrelizumab, CTO 002-50
Primary DI / UDI-DI
03532672000202
Basic UDI-DI
353267CTO002AV7
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
  • Animal Tissues
  • Reagent
  • Professional Testing
  • New Device
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED e9d0ff8e-eead-4d67-b924-445e6c997a36 61 fields · synced 22 Oct 2026