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VITROS™ ECL Multi Control Cardiac Marker

by Shenzhen Lifotronic Technology Co., Ltd. China EUDAMED

Ref QO691028Model Low value: 3 × 2.0 mL, High value: 3 × 2.0 mL; Low value: 6 × 2.0 mL, High value: 6 × 2.0 mL; Level 1: 6×2.0 mL, Level 2: 6×2.0 mL

EMDN W0102152004

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6970341680320500701LJ Basic UDI-DIDate10 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Multi Control Cardiac Marker
Model / Reference
Low value: 3 × 2.0 mL, High value: 3 × 2.0 mL, Low value: 6 × 2.0 mL, High value: 6 × 2.0 mL, Level 1: 6×2.0 mL, Level 2: 6×2.0 mL, QO691028
Primary DI / UDI-DI
06978139076637
Basic UDI-DI
6970341680320500701LJ
EMDN Code
W0102152004 Cardiac marker controls
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000005654
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Lifotronic Technology Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06978139076637|6970341680320500701LJ 61 fields · synced 24 Oct 2026