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Calibrator Solution for Urine Analyzer

by URIT Medical Electronic Co., Ltd. EUDAMED

Active European Union

Ref USUC00001091, USUC00001095, USUC00001089, /Model URIT YC 2ST、UNAMAX SG Calibrator、UNAMAX TURBIDITY Calibrator, Quality control solution for urine analyzer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69357407IUCS000006QW Basic UDI-DIDate11 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
URIT YC 2ST、UNAMAX SG Calibrator、UNAMAX TURBIDITY Calibrator, USUC00001091, USUC00001095, USUC00001089, Quality control solution for urine analyzer, /
Primary DI / UDI-DI
06935740750295, 06935740750271, 06935740750233, D-1-66C
Basic UDI-DI
69357407IUCS000006QW, B-1-66C
EMDN Code
W010106020602 Urine testing calibrators and standards
Device Class
Class B
Class IVD General
Market of Registration
Germany
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

  • 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