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Urine Reagent Strips

by URIT Medical Electronic Co., Ltd. China EUDAMED

Ref W0101060204Model URIT 11FA、URIT 12FA、URIT 14FA、LabUSticks 11F、LabUSticks 12F、LabUSticks 14F EMDN W0101060204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69357407IUCS000010QM Basic UDI-DIDate5 Aug 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Urine Reagent Strips
Model / Reference
URIT 11FA、URIT 12FA、URIT 14FA、LabUSticks 11F、LabUSticks 12F、LabUSticks 14F, W0101060204
Primary DI / UDI-DI
06935740753692
Basic UDI-DI
69357407IUCS000010QM
Unit of Use DI
86935740753698
EMDN Code
W0101060204 Urine multi-constituent test strips (manual)
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 06935740753692|69357407IUCS000010QM 61 fields · synced 25 Oct 2026