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ReLIA

by ReLIA Biotechnologies (Jiangsu), Inc. China EUDAMED

Ref RF16065-20T

EMDN W01021499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06971354100477 Basic UDI-DIDate21 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 24 Oct 2026

Device Name
Cardiac Troponin I /Creatine Kinase Isoenzyme-MB /Myoglobin Test (Fluorescence Immunoassay)
Model / Reference
RF16065-20T
Primary DI / UDI-DI
06971354100477
Basic UDI-DI
B-06971354100477
EMDN Code
W01021499 Multiple immunochemistry reagents - other
Device Class
Class IVD General
Market of Registration
Slovenia

Manufacturer details

EUDAMED SRN
CN-MF-000042042
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

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    IVD General

  • ReLIA

    IVD General

  • ReLIA

    IVD General

  • ReLIA

    IVD General

See all devices from ReLIA Biotechnologies (Jiangsu), Inc. →

Properties & raw data

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

Sources (1)

  • EUDAMED e365c18b-8eab-45ab-a566-323be0909ec8 61 fields · synced 24 Oct 2026