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Calibrator Solution for Urine Analyzer

by URIT Medical Electronic Co., Ltd. China EUDAMED

Ref USUC00001097Model URIT YC 2ST、UNAMAX SG Calibrator、UNAMAX TURBIDITY Calibrator

EMDN W010106020602

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69357407IUCS000006QW 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 25 Oct 2026

Device Name
Calibrator Solution for Urine Analyzer
Model / Reference
URIT YC 2ST、UNAMAX SG Calibrator、UNAMAX TURBIDITY Calibrator, USUC00001097
Primary DI / UDI-DI
06935740753777
Basic UDI-DI
69357407IUCS000006QW
EMDN Code
W010106020602 Urine testing calibrators and standards
Device Class
Class B
Market of Registration
Italy

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 06935740753777|69357407IUCS000006QW 61 fields · synced 25 Oct 2026