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DAY Anti-s P3BER

by Haemokinesis Ltd Australia EUDAMED

Ref 22901-1 EMDN W0103030501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-09354330001338 Basic UDI-DIDate30 Oct 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
22901-1
Primary DI / UDI-DI
09354330001338
Basic UDI-DI
B-09354330001338
EMDN Code
W0103030501 Other antigen typing reagents
Device Class
Class IVD General
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
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 851118ad-c01b-49bb-8e4a-8e30c19021c7 61 fields · synced 24 Oct 2026