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Urine Reagent Strips

by URIT Medical Electronic Co., Ltd. China EUDAMED

Ref USUC00000605,USUC00001033Model UC 10ACR、UC 10GA、UC 11GA、UC 12GA、UC 13GA、UC 14GA EMDN W0101060204

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69357407IUCS000011QP Basic UDI-DIDate12 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
UC 10ACR、UC 10GA、UC 11GA、UC 12GA、UC 13GA、UC 14GA, USUC00000605, USUC00001033
Primary DI / UDI-DI
06935740723589
Basic UDI-DI
69357407IUCS000011QP
Unit of Use DI
86935740723585
EMDN Code
W0101060204 Urine multi-constituent test strips (manual)
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 06935740723589|69357407IUCS000011QP 61 fields · synced 24 Oct 2026