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Urine Analyzer

by URIT Medical Electronic Co., Ltd. China EUDAMED510(k)

Ref /, USUC00001053, USUC00001107, USUC00001055, USUC00001057, USUC00000516,USUC00001064, USUC00000166,USUC00001067, USUC00000603,USUC00001031, USUC00000175,USUC00001068, USUC00000608,USUC00001036, USUC00000178,USUC00001070, USUC00000177,USUC00001069, USUC00000607,USUC00001035Model URIT-31、UC-32A、UC-32B、URIT-50、URIT-180、URIT-330、URIT-500、URIT-500C、URIT-560、UC-58、UC-280A、UC-280B、UC-600A、UC-50A、UC-50B、UC-50C、UNAMAX ONE、UNAMAX LITE, URIT 1VK、URIT 1VP、URIT 1VG、URIT 2VGK、URIT 2VPG、URIT 3VPGp、URIT 4VPGpSP、URIT 5V、URIT 9V、URIT 10V、URIT 11V、URIT 12V, URIT 10G、URIT 11G、URIT 14G、LabUSticks 10G、LabUSticks 11G、LabUSticks 14G, HC-ACR、HC- 2U、HC-2D、HC-4U、HC-4K、HC-4D、HC-8T、HC-10T、HC-12TA、HC-14ACR, URIT 11F、URIT 12F, UC 10ACR、UC 10GA、UC 11GA、UC 12GA、UC 13GA、UC 14GA, UC-1800、URIT-1600、UNAMAX510(k) K232317 Product code JIOEMDN W020101020102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number69357407IUC000002WV Basic UDI-DIDate5 Aug 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK232317 Date26 Apr 2024ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/IVDR Active

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 25 Oct 2026

Trade Name
Urine Reagent Strips
Device Name
Urine Analyzer
Automatic Urine Analyzer
Model / Reference
URIT-31、UC-32A、UC-32B、URIT-50、URIT-180、URIT-330、URIT-500、URIT-500C、URIT-560、UC-58、UC-280A、UC-280B、UC-600A、UC-50A、UC-50B、UC-50C、UNAMAX ONE、UNAMAX LITE, /, URIT 1VK、URIT 1VP、URIT 1VG、URIT 2VGK、URIT 2VPG、URIT 3VPGp、URIT 4VPGpSP、URIT 5V、URIT 9V、URIT 10V、URIT 11V、URIT 12V, USUC00001053, USUC00001107, USUC00001055, URIT 10G、URIT 11G、URIT 14G、LabUSticks 10G、LabUSticks 11G、LabUSticks 14G, USUC00001057, HC-ACR、HC- 2U、HC-2D、HC-4U、HC-4K、HC-4D、HC-8T、HC-10T、HC-12TA、HC-14ACR, USUC00000516, USUC00001064, USUC00000166, USUC00001067, URIT 11F、URIT 12F, UC 10ACR、UC 10GA、UC 11GA、UC 12GA、UC 13GA、UC 14GA, USUC00000603, USUC00001031, USUC00000175, USUC00001068, USUC00000608, USUC00001036, USUC00000178, USUC00001070, UC-1800、URIT-1600、UNAMAX, USUC00000177, USUC00001069, USUC00000607, USUC00001035
Primary DI / UDI-DI
06935740723503, 06935740726375, 06935740722025, 06935740749329, 06935740714310, 06935740714327, 06935740714334, 06935740731744, 06935740714112, 06935740727075, 06935740715102, 06935740715256, 06935740723510, 06935740723411, 06935740749336, 06935740714136, 06935740723565, 06935740715522, 06935740723619, 06935740715034, 06935740723497, 06935740715058, 06935740749312, 06935740723602, 06935740714105
Basic UDI-DI
69357407IUC000002WV, 69357407IUCS000007QY, 69357407IUCS000012QR, 69357407IUCS000014QV, 69357407IUCS000009R4, 69357407IUCS000011QP, 69357407IUC000001WT
Unit of Use DI
86935740714316, 86935740714323, 86935740714330, 86935740714118, 86935740727071, 86935740715108, 86935740715252, 86935740714132, 86935740723561, 86935740715528, 86935740723615, 86935740715030, 86935740715054, 86935740723608, 86935740714101
Direct Marketing DI
06935740723503
06935740726375
06935740722025
06935740749329
06935740731744
06935740723510
06935740723411
06935740749336
06935740723497
06935740749312
510(k) Number
FDA Product Code
JIO
EMDN Code
W020101020102, W0101060204, W020101020103
Device Class
Class A EUDAMED
Class B EUDAMED
Class II 510(k)
Regulation
21 CFR Part 864.6550
Market of Registration
Germany
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class A
Class B
510(k)
Class II

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 NoEUDAMEDYesEUDAMED
  • Professional Testing
  • Surgical Instrument YesEUDAMEDNoEUDAMED
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (26)

  • EUDAMED 5c0d9e74-c7cb-4e24-a1b5-995e182a5110 61 fields · synced 24 Oct 2026
  • EUDAMED 06935740726375|69357407IUC000002WV 61 fields · synced 16 May 2026
  • EUDAMED 06935740722025|69357407IUC000002WV 61 fields · synced 16 May 2026
  • EUDAMED 06935740749329|69357407IUC000002WV 61 fields · synced 16 May 2026
  • EUDAMED 06935740714310|69357407IUCS000007QY 61 fields · synced 16 May 2026
  • EUDAMED 06935740714327|69357407IUCS000007QY 61 fields · synced 17 May 2026
  • EUDAMED 06935740714334|69357407IUCS000007QY 61 fields · synced 17 May 2026
  • EUDAMED 06935740731744|69357407IUC000002WV 61 fields · synced 17 May 2026
  • EUDAMED 06935740714112|69357407IUCS000012QR 61 fields · synced 17 May 2026
  • EUDAMED 06935740727075|69357407IUCS000007QY 61 fields · synced 18 May 2026
  • FDA 510(k) K232317 24 fields · synced 18 May 2026
  • EUDAMED 06935740715102|69357407IUCS000014QV 61 fields · synced 8 Jul 2026
  • EUDAMED 06935740715256|69357407IUCS000014QV 61 fields · synced 9 Jul 2026
  • EUDAMED 06935740723510|69357407IUC000002WV 61 fields · synced 9 Jul 2026
  • EUDAMED 06935740723411|69357407IUC000002WV 61 fields · synced 10 Jul 2026
  • EUDAMED 06935740749336|69357407IUC000002WV 61 fields · synced 11 Jul 2026
  • EUDAMED 06935740714136|69357407IUCS000009R4 61 fields · synced 14 Jul 2026
  • EUDAMED 06935740723565|69357407IUCS000011QP 61 fields · synced 14 Jul 2026
  • EUDAMED 06935740715522|69357407IUCS000014QV 61 fields · synced 15 Jul 2026
  • EUDAMED 06935740723619|69357407IUCS000011QP 61 fields · synced 15 Jul 2026
  • EUDAMED 06935740715034|69357407IUCS000014QV 61 fields · synced 15 Jul 2026
  • EUDAMED 06935740723497|69357407IUC000001WT 61 fields · synced 24 Jul 2026
  • EUDAMED 06935740715058|69357407IUCS000014QV 61 fields · synced 28 Jul 2026
  • EUDAMED 06935740749312|69357407IUC000002WV 61 fields · synced 3 Aug 2026
  • EUDAMED 06935740723602|69357407IUCS000011QP 61 fields · synced 4 Aug 2026
  • EUDAMED 06935740714105|69357407IUCS000012QR 61 fields · synced 25 Oct 2026