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Chest Pain Triage algorithm 1.1

by Roche Diagnostics GmbH Germany EUDAMED

Ref 09883746001 EMDN W0201020292

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number761333603460AY Basic UDI-DIDate29 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V76 010283 0738 Supplemented

    Technical documentation EU IVDR

    Notified body
    TÜV SÜD Product Service GmbH 0123
    Issued
    2 Jul 2026
    Expires
    20 Nov 2029
    Reason
    Change approved

Specification

EUDAMED · synced 25 Oct 2026

Device Name
chest pain triage algorithm 1.x
Model / Reference
09883746001
Primary DI / UDI-DI
07613336242346
Basic UDI-DI
761333603460AY
EMDN Code
W0201020292 Limited panel immunochemistry analysers - IVD medical device software
Device Class
Class C
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006260

Other devices from Roche Diagnostics GmbH

See all devices from Roche Diagnostics GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 07613336242346|761333603460AY 61 fields · synced 25 Oct 2026