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KEYU Urine Analyzer Physical Multicontrol

by Zhuhai Keyu Biological Engineering Co., Ltd EUDAMED

Active European Union

Ref UM-QC

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974735361894 Basic UDI-DIDate8 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Urine Analyzer Physical Multicontrol
Model / Reference
UM-QC
Primary DI / UDI-DI
06974735361894, 06974735362389
Basic UDI-DI
B-06974735361894, B-06974735362389
EMDN Code
W0101050101 Assayed multicomponent controls (cc)
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000023195
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zhuhai Keyu Biological Engineering Co., Ltd

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

Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No