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hs-TnI (CLIA)

by Medcaptain Medical Technology Co., Ltd. United States EUDAMED

Ref MCL01605E

EMDN W01021306

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06926802605684 Basic UDI-DIDate22 Sep 2026RegisteredStatusActive

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 25 Oct 2026

Device Name
hs-TnI (CLIA)
Model / Reference
MCL01605E
Primary DI / UDI-DI
06926802605684
Basic UDI-DI
B-06926802605684
EMDN Code
W01021306 Troponin i/t
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000005925
Authorised representative
R Sight B.V. NL-AR-000010445

Other devices from Medcaptain Medical Technology Co., Ltd.

See all devices from Medcaptain Medical Technology Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 06926802605684|B-06926802605684 61 fields · synced 25 Oct 2026