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S100 (eCLIA)

by Shenzhen Lifotronic Technology Co., Ltd. China EUDAMED

Ref 0320509102Model 2×50 T, 50T, 2×50T, 100T, 2×100T

EMDN W0102030399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06975984063744 Basic UDI-DIDate20 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
2×50 T, 0320509102, 50T, 2×50T, 100T, 2×100T
Primary DI / UDI-DI
06975984063744
Basic UDI-DI
B-06975984063744, 69703416803205101J2
EMDN Code
W0102030399, W0102019099
Device Class
Class IVD General
Class C
Market of Registration
Netherlands
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 (2)

  • EUDAMED a51257e6-e24b-4322-8832-21345c8ec8ea 61 fields · synced 22 Oct 2026
  • EUDAMED 06975984063744|69703416803205101J2 61 fields · synced 20 Oct 2026