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Multi Control Cardiac Marker II

by Shenzhen Lifotronic Technology Co., Ltd. China EUDAMED

Ref 0320514403Model Level 1, Level 2, Level 3: 2×2.0mL； Level 1, Level 2, Level 3: 4×2.0mL； Level 1: 3×2.0mL； Level 2: 3×2.0mL； Level 3: 3×2.0mL； Level 1: 6×2.0mL； Level 2: 6×2.0mL； Level 3: 6×2.0mL

EMDN W0102152004

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6970341680320501501LF Basic UDI-DIDate6 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
Level 1, Level 2, Level 3: 2×2.0mL； Level 1, Level 3: 4×2.0mL； Level 1: 3×2.0mL； Level 2: 3×2.0mL； Level 3: 3×2.0mL； Level 1: 6×2.0mL； Level 2: 6×2.0mL； Level 3: 6×2.0mL, 0320514403
Primary DI / UDI-DI
06978139073285
Basic UDI-DI
6970341680320501501LF
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.

See all devices from Shenzhen Lifotronic Technology Co., Ltd. →

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 06978139073285|6970341680320501501LF 61 fields · synced 23 Oct 2026