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KEYU Dry Chemistry Urine Analyzer

by Zhuhai Keyu Biological Engineering Co., Ltd China EUDAMED

Ref KU-U200A EMDN W020101020101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697473536KUA03P8 Basic UDI-DIDate9 May 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Dry Chemistry Urine Analyzer
Model / Reference
KU-U200A
Primary DI / UDI-DI
06974735362396
Basic UDI-DI
697473536KUA03P8
EMDN Code
W020101020101 Urine strip readers
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

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Properties & raw data

Show properties, registry sources and raw records
  • Surgical Instrument
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 06974735362396|697473536KUA03P8 61 fields · synced 24 Oct 2026