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DAY Dilution Plates

by Haemokinesis Ltd Australia EUDAMED

Ref 09310-20

EMDN W0580

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number9354330009310YX Basic UDI-DIDate14 Apr 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
09310-20
Primary DI / UDI-DI
09354330001888
Basic UDI-DI
9354330009310YX
EMDN Code
W0580 IVD general use consumables devices - other accessories
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
AU-MF-000033867
Authorised representative
Compliance Management Solutions Europe LTD BG-AR-000020809

Other devices from Haemokinesis Ltd

See all devices from Haemokinesis Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • 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
  • New Device: No

Sources (1)

  • EUDAMED bdb18574-9163-4ac7-8dc9-467d4569136e 61 fields · synced 24 Oct 2026