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IMMUNO-TROL i-Tracker Anti-Ustekinumab

by Biosynex France EUDAMED

Ref CTU 003-PC

EMDN W0102152001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-03532672000318 Basic UDI-DIDate8 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
CTU 003-PC
Primary DI / UDI-DI
03532672000318
Basic UDI-DI
B-03532672000318
EMDN Code
W0102152001 Tdm/drug controls
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000042615

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
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 410c3e50-05a8-4544-b753-3d6f663815a0 61 fields · synced 24 Oct 2026