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Fluorescence immunochromatography analyzer LEPU Quant-Fluo800

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

Ref JY05LEPU Quant-Fluo 800Model LEPU Quant-Fluo800 EMDN W02010299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number692180760072EY 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  • Withdrawn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 22 Oct 2026

Model / Reference
LEPU Quant-Fluo800, JY05LEPU Quant-Fluo 800
Primary DI / UDI-DI
06921807600726
Basic UDI-DI
692180760072EY
Direct Marketing DI
06921807600726
EMDN Code
W02010299 Immunochemistry instruments - other
Device Class
Class A
Market of Registration
Belgium

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 533a9280-21b2-4f2a-8973-fd359cf5c46f 61 fields · synced 22 Oct 2026