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Urine Analyzer

by URIT Medical Electronic Co., Ltd. EUDAMED

Active European Union

Ref /Model URIT-31、UC-32A、UC-32B、URIT-50、URIT-180、URIT-330、URIT-500、URIT-500C、URIT-560、UC-58、UC-280A、UC-280B、UC-600A、UC-50A、UC-50B、UC-50C、UNAMAX ONE、UNAMAX LITE

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69357407IUC000002WV Basic UDI-DIDate5 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR 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
Model / Reference
URIT-31、UC-32A、UC-32B、URIT-50、URIT-180、URIT-330、URIT-500、URIT-500C、URIT-560、UC-58、UC-280A、UC-280B、UC-600A、UC-50A、UC-50B、UC-50C、UNAMAX ONE、UNAMAX LITE, /
Primary DI / UDI-DI
06935740723428
Basic UDI-DI
69357407IUC000002WV
Direct Marketing DI
06935740723428
EMDN Code
W020101020102 Semi-automated urine analysers
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000011840
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from URIT Medical Electronic Co., Ltd.

See all devices from URIT Medical Electronic Co., Ltd. →

Properties

  • 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