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STARGEL10 Neutral

by Haemokinesis Ltd Australia EUDAMED

Ref GT2010-10, GT2010-100 EMDN W01030399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number93543300GT20108M Basic UDI-DIDate27 Mar 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
GT2010-10, GT2010-100
Primary DI / UDI-DI
09354330000263, 09354330000270
Basic UDI-DI
93543300GT20108M
EMDN Code
W01030399 Immunohaematology (blood grouping) tests - other
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
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 5adb53d5-d65e-4bfb-a264-e8c9514bf2d1 61 fields · synced 22 Oct 2026
  • EUDAMED 09354330000270|93543300GT20108M 61 fields · synced 17 May 2026