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IMMUNO-TROL i-Tracker Anti-Adalimumab Total Ab

by Biosynex EUDAMED

Active European Union

Ref CTA 003T-PC, LTA 003-PC, CTA 002-PC, LTA 002-PCModel IMMUNO-TROL i-Tracker Anti-Adalimumab Total Ab

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number353267CTA003TPCAZA Basic UDI-DIDate25 Jul 2025RegisteredStatusActive
European UnionCE/IVDR Number353267CTA003TPCAZA Basic UDI-DIDate25 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED

Trade Name
IMMUNO-TROL i-Tracker Anti-Adalimumab Total Ab
IMMUNO-TROL Anti-Adalimumab
IMMUNO-TROL i-Tracker Adalimumab
IMMUNO-TROL Adalimumab
Model / Reference
IMMUNO-TROL i-Tracker Anti-Adalimumab Total Ab, CTA 003T-PC, LTA 003-PC, CTA 002-PC, LTA 002-PC
Primary DI / UDI-DI
03532672001520, 03532672000899, 03532672000264, 03532672000882
Basic UDI-DI
353267CTA003TPCAZA, B-03532672000899, B-03532672000264, B-03532672000882
Direct Marketing DI
03532672001520
EMDN Code
W0102152001 Tdm/drug controls
Device Class
Class B
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000042615

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Properties

  • 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