Skip to content

Staphylococcus typing 8-well

by AusDiagnostics Pty Ltd Australia EUDAMED

Ref 21341P

EMDN W0105011203

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-09343044002694 Basic UDI-DIDate27 Oct 2023RegisteredStatusActive

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

Device Name
Step 2 Plates for Staphylococcus typing 8-well
Model / Reference
21341P
Primary DI / UDI-DI
09343044002694
Basic UDI-DI
B-09343044002694
EMDN Code
W0105011203 Staphylococcal detection by na reagents
Device Class
Class IVD General
Market of Registration
Malta

Manufacturer details

EUDAMED SRN
AU-MF-000020558
Authorised representative
Advena Limited MT-AR-000000234

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 4cb7b41e-4f03-4353-8a72-2742afc51573 61 fields · synced 22 Oct 2026