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iStar-hs-Troponin-I Ⅱ

by Shenzhen Drawray Biotech Co., Ltd. China EUDAMED

Ref DC76127Model 2×50 Tests/kit EMDN W01021306

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-DC76127FL Basic UDI-DIDate25 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
2×50 Tests/kit, DC76127
Primary DI / UDI-DI
D-DC76127FL
Basic UDI-DI
B-DC76127FL
EMDN Code
W01021306 Troponin i/t
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000008763
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Shenzhen Drawray Biotech Co., Ltd.

See all devices from Shenzhen Drawray Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-DC76127FL|B-DC76127FL 61 fields · synced 24 Oct 2026