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EntericBio® Clostridioides difficile

by Serosep Limited Ireland EUDAMED

Ref EBCDA-V2

EMDN W0105011804

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05391513879166 Basic UDI-DIDate4 Jul 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
EBCDA-V2
Primary DI / UDI-DI
05391513879166
Basic UDI-DI
B-05391513879166
EMDN Code
W0105011804 C.difficile by na reagents
Device Class
Class IVD General
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000020322

Other devices from Serosep, Ltd.

See all devices from Serosep, Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 52c45551-7e9e-4108-8a06-f34ea3b257f1 61 fields · synced 24 Oct 2026