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Urine Reagent Strips

by URIT Medical Electronic Co., Ltd. China EUDAMED

Ref USUC00000165,USUC00001063Model HC-ACR、HC- 2U、HC-2D、HC-4U、HC-4K、HC-4D、HC-8T、HC-10T、HC-12TA、HC-14ACR EMDN W0101060204

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69357407IUCS000014QV 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  • Withdrawn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 25 Oct 2026

Model / Reference
HC-ACR、HC- 2U、HC-2D、HC-4U、HC-4K、HC-4D、HC-8T、HC-10T、HC-12TA、HC-14ACR, USUC00000165, USUC00001063
Primary DI / UDI-DI
06935740715225
Basic UDI-DI
69357407IUCS000014QV
Unit of Use DI
86935740715221
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 06935740715225|69357407IUCS000014QV 61 fields · synced 25 Oct 2026