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Quality Control Solution for Urine Analyzer

by URIT Medical Electronic Co., Ltd. China EUDAMED

Ref USUC00001086Model URIT YQ 3STC、UNAMAX SG Control、UNAMAX COLOR Control、UNAMAX TURBIDITY Control

EMDN W010106020601

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69357407IUCS000005QU Basic UDI-DIDate11 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
URIT YQ 3STC、UNAMAX SG Control、UNAMAX COLOR Control、UNAMAX TURBIDITY Control, USUC00001086
Primary DI / UDI-DI
06935740750202
Basic UDI-DI
69357407IUCS000005QU
EMDN Code
W010106020601 Urine testing controls
Device Class
Class B
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 & 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 5fa0c3db-bb74-4a62-99b4-8c6eeb4f1fef 61 fields · synced 22 Oct 2026