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ThromboGUARD FII FV

by Appolon Bioteck France EUDAMED

Ref AB0040 EMDN W0106010115

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number376032282CGENF2F5FW Basic UDI-DIDate25 Jul 2025RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Model / Reference
AB0040
Primary DI / UDI-DI
03760322820157
Basic UDI-DI
376032282CGENF2F5FW
EMDN Code
W0106010115 Combined factor ii / factor v leiden
Device Class
Class C
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000022234

Other devices from Appolon Bioteck

See all devices from Appolon Bioteck →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 8c95f451-e0ed-4719-9687-003704534964 61 fields · synced 24 Oct 2026