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STATUS1 Solution

by Haemokinesis Ltd Australia EUDAMED

Ref TT1003

EMDN W0103030306

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number93543300TT1003DS Basic UDI-DIDate27 Mar 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
TT1003
Primary DI / UDI-DI
09354330000058
Basic UDI-DI
93543300TT1003DS
EMDN Code
W0103030306 Enhancement media (e.g. bovine albumin, liss, peg)
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
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 8dcd01e4-8bcc-495e-bac8-1775e97c0733 61 fields · synced 22 Oct 2026