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Urine Reagent Strips

by URIT Medical Electronic Co., Ltd. EUDAMED

Active European Union

Ref USUC00001043Model URIT 1VK、URIT 1VP、URIT 1VG、URIT 2VGK、URIT 2VPG、URIT 3VPGp、URIT 4VPGpSP、URIT 5V、URIT 9V、URIT 10V、URIT 11V、URIT 12V

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69357407IUCS000007QY Basic UDI-DIDate9 Jan 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
URIT 1VK、URIT 1VP、URIT 1VG、URIT 2VGK、URIT 2VPG、URIT 3VPGp、URIT 4VPGpSP、URIT 5V、URIT 9V、URIT 10V、URIT 11V、URIT 12V, USUC00001043
Primary DI / UDI-DI
06935740714273
Basic UDI-DI
69357407IUCS000007QY
Unit of Use DI
86935740714279
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