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hs-cTnI Test Kit (Fluorescence Immunoassay)

by Wuxi Biohermes Bio & Medical Technology Co., Ltd. China EUDAMED

Ref BF-S155Model BF S15 EMDN W0102160703

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CNMF000014455-BF-S155RV Basic UDI-DIDate3 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  • Withdrawn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 25 Oct 2026

Device Name
hs-cTnI Test Kit (Fluorescence Immunoassay)
Model / Reference
BF S15, BF-S155
Primary DI / UDI-DI
D-CNMF000014455-BF-S155RV
Basic UDI-DI
B-CNMF000014455-BF-S155RV
EMDN Code
W0102160703 Troponin i/t - rt & poc
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000014455
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Wuxi Biohermes Bio & Medical Technology Co., Ltd.

See all devices from Wuxi Biohermes Bio & Medical Technology Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED D-CNMF000014455-BF-S155RV|B-CNMF000014455-BF-S155RV 61 fields · synced 25 Oct 2026