Skip to content

Innodx ST2 Stat Cmia

by Xiamen Innodx Biotech Co., Ltd. China EUDAMED

Ref KR-ST2 STAT-05100 EMDN W01021314

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number697360079030JQ Basic UDI-DIDate5 May 2026RegisteredStatusActive
European UnionCE/IVDR Number697360079030JQ Basic UDI-DIDate5 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
KR-ST2 STAT-05100
Primary DI / UDI-DI
06973600799817, D-KR-ST2STAT-05100XH
Basic UDI-DI
697360079030JQ, B-KR-ST2STAT-05100XH
EMDN Code
W01021314 St2
Device Class
Class C
Class IVD General
Market of Registration
Belgium
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000041071
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Xiamen Innodx Biotech Co., Ltd.

See all devices from Xiamen Innodx Biotech Co., 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 4069f964-8738-4112-9df5-745a2accced2 61 fields · synced 22 Oct 2026
  • EUDAMED D-KR-ST2STAT-05100XH|B-KR-ST2STAT-05100XH 61 fields · synced 20 Jul 2026