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RIDA®Plex Positive Control Respiratory Pathogens

by AusDiagnostics Pty Ltd Australia EUDAMED

Ref 91011 EMDN W0105080807

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-09343044006807 Basic UDI-DIDate17 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
91011
Primary DI / UDI-DI
09343044006807
Basic UDI-DI
B-09343044006807
EMDN Code
W0105080807 Multiconstituent controls - inf.imm.
Device Class
Class IVD Annex II List B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
AU-MF-000020558
Authorised representative
R-Biopharm AG DE-AR-000050025

From the manufacturer

Manufacturer's product page: Respiratory Pathogens

Other devices from AusDiagnostics Pty Ltd

See all devices from AusDiagnostics Pty Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 2a772ef5-f4c7-492f-a557-ee9396ec644d 61 fields · synced 25 Oct 2026