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STARGEL10 Satellite Reader

by Haemokinesis Ltd Australia EUDAMED

Ref GT2015Model STARGEL10

EMDN W0202030201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-09354330000577 Basic UDI-DIDate27 Mar 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

Model / Reference
STARGEL10, GT2015
Primary DI / UDI-DI
09354330000577
Basic UDI-DI
B-09354330000577
EMDN Code
W0202030201 Immunohematology readers
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
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED 4367ffe8-6e2a-4204-a709-d9272a6dae7a 61 fields · synced 22 Oct 2026