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Respiratory Pathogens B 16-well

by AusDiagnostics Pty Ltd Australia EUDAMED

Ref 20612P EMDN W0105070503

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-09343044001444 Basic UDI-DIDate27 Oct 2023RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Device Name
Step 2 Plates for Respiratory Pathogens B 16-well
Model / Reference
20612P
Primary DI / UDI-DI
09343044001444
Basic UDI-DI
B-09343044001444
EMDN Code
W0105070503 Respiratory tract infections - multiplex na reagents
Device Class
Class IVD Annex II List B
Market of Registration
Malta

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 6882edec-ee52-45b1-930e-475a804e7225 61 fields · synced 24 Oct 2026