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i-Tracker Anti-Infliximab Total Ab

by Biosynex EUDAMED

Active European Union

Ref CTI 003T-50, CTI 003-100, CTI 002-100Model i-Tracker Anti-Infliximab Total Ab

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number353267CTI003TASR Basic UDI-DIDate2 Jun 2025RegisteredStatusActive
European UnionCE/IVDR Number353267CTI003TASR Basic UDI-DIDate2 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Trade Name
i-Tracker Anti-Infliximab Total Ab
i-Tracker Anti-Infliximab
i-Tracker Infliximab
Model / Reference
i-Tracker Anti-Infliximab Total Ab, CTI 003T-50, CTI 003-100, CTI 002-100
Primary DI / UDI-DI
03532672000240, 03532672000035, 03532672000028
Basic UDI-DI
353267CTI003TASR, B-03532672000035, B-03532672000028
EMDN Code
W0102080799, W0102080701
Device Class
Class B
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000042615

Other devices from Biosynex

See all devices from Biosynex →

Properties

Show properties
  • 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