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KEYU Sample Diluent

by Zhuhai Keyu Biological Engineering Co., Ltd China EUDAMED

Ref KU-C02-1

EMDN W0101070304

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697473536KUC05PN Basic UDI-DIDate7 May 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
Sample Diluent
Model / Reference
KU-C02-1
Primary DI / UDI-DI
06974735362433
Basic UDI-DI
697473536KUC05PN
EMDN Code
W0101070304 Common buffers and solutions (electrolytes)
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000023195
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Zhuhai Keyu Biological Engineering Co., Ltd

See all devices from Zhuhai Keyu Biological Engineering Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06974735362433|697473536KUC05PN 61 fields · synced 24 Oct 2026