Skip to content

Urine Reagent Strips

by URIT Medical Electronic Co., Ltd. EUDAMED

Active European Union

Ref /, USUC00001047Model URIT 14F, 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 Number69357407IUCS000001QL 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  • Withdrawn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

Model / Reference
URIT 14F, /, URIT 1VK、URIT 1VP、URIT 1VG、URIT 2VGK、URIT 2VPG、URIT 3VPGp、URIT 4VPGpSP、URIT 5V、URIT 9V、URIT 10V、URIT 11V、URIT 12V, USUC00001047
Primary DI / UDI-DI
06935740714204, 06935740714280
Basic UDI-DI
69357407IUCS000001QL, 69357407IUCS000007QY
Unit of Use DI
86935740714200, 86935740714286
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