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Alinity

by Abbott Ireland Diagnostics Division Ireland EUDAMED

Ref 08P1310

EMDN W0102152004

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number038074AIP0813L6 Basic UDI-DIDate18 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Alinity i STAT High Sensitive Troponin-I Reagent Kit
Model / Reference
08P1310
Primary DI / UDI-DI
00380740130725
Basic UDI-DI
038074AIP0813L6
EMDN Code
W0102152004 Cardiac marker controls
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IE-MF-000010070

Other devices from Abbott Ireland Diagnostics Division

See all devices from Abbott Ireland Diagnostics Division →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 00380740130725|038074AIP0813L6 61 fields · synced 24 Oct 2026