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EntericBio Workstation

by Serosep Limited Ireland EUDAMED

Ref 5070000450Model EntericBio Workstation

EMDN W02060199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0539151387INST2R Basic UDI-DIDate5 Aug 2022RegisteredStatusActive

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
EntericBio Workstation, 5070000450
Primary DI / UDI-DI
05391513879630
Basic UDI-DI
0539151387INST2R
Direct Marketing DI
05391513879630
EMDN Code
W02060199 Robotic sample processing systems - other
Device Class
Class A
Special Device Type
Software
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000020322

Other devices from Serosep Limited

See all devices from Serosep Limited →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
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
  • New Device: No

Sources (1)

  • EUDAMED 92e8d890-c2d0-41ac-9f41-027d928c9f77 61 fields · synced 22 Oct 2026