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BIOSYNEX C. difficile GDH

by Biosynex France EUDAMED

Ref 1030008Model BIOSYNEX C. difficile GDH

EMDN W0105090106

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number353267F00076P8N Basic UDI-DIDate5 Mar 2026RegisteredStatusActive

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
BIOSYNEX C. difficile GDH, 1030008
Primary DI / UDI-DI
03532678592862
Basic UDI-DI
353267F00076P8N
EMDN Code
W0105090106 Clost. diff. incl gdh and/or toxin a and b - rt & poc
Device Class
Class B
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000014073

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 (1)

  • EUDAMED 30a329b6-bb13-45f4-91fe-bb170d91a62b 61 fields · synced 22 Oct 2026