Skip to content

IMMUNO-TROL i-Tracker Etanercept

by Biosynex France EUDAMED

Ref CTE 002-PC, LTE 002-PCModel IMMUNO-TROL i-Tracker Etanercept EMDN W0102152001

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number353267CTE002PCARL Basic UDI-DIDate22 Jul 2025RegisteredStatusActive
European UnionCE/IVDR Number353267CTE002PCARL Basic UDI-DIDate22 Jul 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  • Withdrawn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 · synced 22 Oct 2026

Trade Name
IMMUNO-TROL i-Tracker Etanercept
IMMUNO-TROL Etanercept
Model / Reference
IMMUNO-TROL i-Tracker Etanercept, CTE 002-PC, LTE 002-PC
Primary DI / UDI-DI
03532672000363, 03532672001001
Basic UDI-DI
353267CTE002PCARL, B-03532672001001
Direct Marketing DI
03532672000363
EMDN Code
W0102152001 Tdm/drug controls
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 & 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 (2)

  • EUDAMED 8e3a68e9-9226-4d7d-98c0-3ff1ab56c696 61 fields · synced 22 Oct 2026
  • EUDAMED 03532672001001|B-03532672001001 61 fields · synced 24 Jul 2026