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EntericBio® Stool Preparation Solution

by Serosep Limited Ireland EUDAMED

Ref EBSPSA-v2

EMDN W0599

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0539151387SPS7Z Basic UDI-DIDate26 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
EntericBio Stool Preparation Solution
Model / Reference
EBSPSA-v2
Primary DI / UDI-DI
05391513879104
Basic UDI-DI
0539151387SPS7Z
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
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
  • 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 8a7f1d92-7b17-47d4-8894-a009faf1e210 61 fields · synced 23 Oct 2026