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ABX Difftrol

by Horiba Abx SAS France EUDAMED

Ref 2062208Model 2062207

EMDN W0103010503

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number361023difftrolXR Basic UDI-DIDate28 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
2062207, 2062208
Primary DI / UDI-DI
03610230008560
Basic UDI-DI
361023difftrolXR
EMDN Code
W0103010503 Multilevel blood controls
Device Class
Class B
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000320

Other devices from Horiba Abx SAS

See all devices from Horiba Abx SAS →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED a83f8177-9b59-4804-9264-e71cb52c23a2 61 fields · synced 22 Oct 2026