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i-Tracker Anti-Etanercept

by Biosynex France EUDAMED

Ref CTE 003-50Model i-Tracker Anti-Etanercept EMDN W0102080799

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number353267CTE003ARU Basic UDI-DIDate19 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
i-Tracker Anti-Etanercept, CTE 003-50
Primary DI / UDI-DI
03532672000110
Basic UDI-DI
353267CTE003ARU
EMDN Code
W0102080799 Autoimmune disease tdm - other
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
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED c4130a13-6907-4cbd-83f3-63e720b3dfb1 61 fields · synced 22 Oct 2026