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by HangZhou Biotest Biotech Co., Ltd. China EUDAMED

Ref MCTNI-LC41

EMDN W0102160703

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-MCTNI-LC41K7 Basic UDI-DIDate19 Aug 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 24 Oct 2026

Device Name
Cardiac Troponin I(cTnI) Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)
Model / Reference
MCTNI-LC41
Primary DI / UDI-DI
D-MCTNI-LC41K7
Basic UDI-DI
B-MCTNI-LC41K7
EMDN Code
W0102160703 Troponin i/t - rt & poc
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000008191
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from HangZhou Biotest Biotech Co., Ltd.

See all devices from HangZhou Biotest Biotech Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED D-MCTNI-LC41K7|B-MCTNI-LC41K7 61 fields · synced 24 Oct 2026