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EntericBio ® CPE

by Serosep Limited Ireland EUDAMED

Ref EBCPE

EMDN W0104080606

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05391513879272 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 23 Oct 2026

Device Name
EntericBio® CPE
Model / Reference
EBCPE
Primary DI / UDI-DI
05391513879272
Basic UDI-DI
B-05391513879272
EMDN Code
W0104080606 Nucleic acid identification - manual / automated carbapenemase
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 5ba9c0ff-8afb-4f8f-a0b4-b73d58ebb68b 61 fields · synced 23 Oct 2026