Skip to content

RespiBio Panel 3

by Serosep Limited Ireland EUDAMED

Ref RBRP3Model RespiBio Panel 3

EMDN W0105070503

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05391513879937 Basic UDI-DIDate25 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 22 Oct 2026

Model / Reference
RespiBio Panel 3, RBRP3
Primary DI / UDI-DI
05391513879937
Basic UDI-DI
B-05391513879937
EMDN Code
W0105070503 Respiratory tract infections - multiplex na reagents
Device Class
Class IVD General
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
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 933b8f7a-9444-44dc-93d7-2883a5f342ef 61 fields · synced 22 Oct 2026