Skip to content

High-sensitivity Troponin I (hs-cTnI ) Quantitative Test Kit(Chemiluminescent Immunoassay, CLIA)

by Jiangsu Confidence Medical Technology Co., Ltd China EUDAMED

Ref 50 tests/kit (including calibration and control)

EMDN W01021306

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06979355927956 Basic UDI-DIDate21 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
High-sensitivity Troponin I (hs-cTnI ) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)
Model / Reference
50 tests/kit (including calibration and control)
Primary DI / UDI-DI
06979355927956
Basic UDI-DI
B-06979355927956
EMDN Code
W01021306 Troponin i/t
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000050949
Authorised representative
JOYSUN GROUP S.L.U ES-AR-000043666

Other devices from Jiangsu Confidence Medical Technology Co., Ltd

See all devices from Jiangsu Confidence Medical Technology Co., Ltd →

Properties & raw data

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

Sources (1)

  • EUDAMED 6ad3ae82-1803-44a5-9f3b-110e473b235b 61 fields · synced 23 Oct 2026