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Fluorescence Immunoassay Analyzer LEPU Quant 1600

by Beijing Lepu Medical Technology Co., Ltd. China EUDAMED

Ref JY20LEPUQuant-Fluo1600Model LEPU Quant-Fluo 1600 EMDN W02010299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number692180760503F6 Basic UDI-DIDate9 Jan 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
LEPU Quant-Fluo 1600, JY20LEPUQuant-Fluo1600
Primary DI / UDI-DI
06921807605035
Basic UDI-DI
692180760503F6
Direct Marketing DI
06921807605035
EMDN Code
W02010299 Immunochemistry instruments - other
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000033011
Authorised representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

Other devices from Beijing Lepu Medical Technology Co., Ltd.

See all devices from Beijing Lepu Medical Technology Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 930905ac-d08f-49f5-8e04-9b9c0ceb1fb4 61 fields · synced 24 Oct 2026