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SPINCHIP hs-cTnI

by bioMérieux SA France EUDAMED

Ref 543779

EMDN W0102160703

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number357302BUDI002308TP Basic UDI-DIDate20 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 40537 Issued

    Technical documentation EU IVDR

    Notified body
    GMED SAS 0459
    Issued
    15 Jun 2026
    Expires
    14 Jun 2031

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
543779
Primary DI / UDI-DI
03573026645298
Basic UDI-DI
357302BUDI002308TP
EMDN Code
W0102160703 Troponin i/t - rt & poc
Device Class
Class C
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000004436

Other devices from Biomerieux SA

See all devices from Biomerieux SA →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 03573026645298|357302BUDI002308TP 61 fields · synced 25 Oct 2026