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IMMUNO-TROL i-Tracker Anti-Infliximab Total Ab

by Biosynex France EUDAMED

Ref CTI 003T-PCModel IMMUNO-TROL i-Tracker Anti-Infliximab Total Ab

EMDN W0102152001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number353267CTI003TPCA65 Basic UDI-DIDate25 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
IMMUNO-TROL i-Tracker Anti-Infliximab Total Ab, CTI 003T-PC
Primary DI / UDI-DI
03532672001537
Basic UDI-DI
353267CTI003TPCA65
Direct Marketing DI
03532672001537
EMDN Code
W0102152001 Tdm/drug controls
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
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 9943b56a-4cda-4327-ada2-9baf80e7a70f 61 fields · synced 22 Oct 2026