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Urine Analyzer

by Hivis Medical Technology Co., Ltd China EUDAMED

Ref V-500Model V-500,V-600,V-700,V-800,V-900,V-500MINI,V-4000,V-5000,V-6000

EMDN W02010701

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697810026UA001CF Basic UDI-DIDate4 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Urine Analyzer
Model / Reference
V-500, V-600, V-700, V-800, V-900, V-500MINI, V-4000, V-5000, V-6000
Primary DI / UDI-DI
06978100261000
Basic UDI-DI
697810026UA001CF
EMDN Code
W02010701 Urinalysis (ur) - laboratory analysers- instruments
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000046009
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Properties & raw data

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

Sources (1)

  • EUDAMED 4a2cf74d-c76b-4618-a635-3b0a5cb72272 61 fields · synced 22 Oct 2026