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Detection Kit for Troponin I/Creatine Kinase Isoenzyme/Myoglobin (Rare earth nano fluorescence immunochromatography)

by Beijing Applied Biological Technologies Co., Ltd. China EUDAMED

Ref IF012

EMDN W01021306

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974323014416 Basic UDI-DIDate15 May 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 22 Oct 2026

Device Name
Detection Kit for Troponin I/Creatine Kinase Isoenzyme/Myoglobin (Rare earth nano fluorescence immunochromatography)
Model / Reference
IF012
Primary DI / UDI-DI
06974323014416
Basic UDI-DI
B-06974323014416
EMDN Code
W01021306 Troponin i/t
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000012338
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

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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 dc984246-4a3b-42da-9e39-059e9807e372 61 fields · synced 22 Oct 2026