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Urine Reagent Strips

by URIT Medical Electronic Co., Ltd. EUDAMED

Active European Union

Ref /Model URIT 11FA、URIT 12FA、URIT 14FA、LabUSticks 11F、LabUSticks 12F、LabUSticks 14F

Regulatory status

as of 28 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  • Withdrawn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

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

Device Name
Urine Reagent Strips
Model / Reference
URIT 11FA、URIT 12FA、URIT 14FA、LabUSticks 11F、LabUSticks 12F、LabUSticks 14F, /
Primary DI / UDI-DI
06935740714167
Basic UDI-DI
69357407IUCS000010QM
Unit of Use DI
86935740714163
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

  • 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