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Automatic Urine Analyzer UC-1800

by Urit Medical Electronic Co., Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06935740750738 UDI-DIDate16 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Automatic Urine Analyzer
Generic Name
Urine analyser IVD, laboratory
Model / Reference
UC-1800
Primary DI / UDI-DI
06935740750738
510(k) Number
FDA Product Code
JFY, CDM, KQO, CEN, JIL, JIN, JIO, JIR, JJB, JMA, JMT, LTX, JRE
GMDN Term
Urine analyser IVD, laboratory
Device Class
Class II
Regulation Number
862.1225, 862.1785, 862.2900, 862.1550, 862.1340, 862.1435, 864.6550, 862.1645, 862.1115, 862.1095, 862.1510, 866.1620, 862.2800
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K232317)

Other devices from Urit Medical Electronic Co., Ltd.

See all devices from Urit Medical Electronic Co., Ltd. →

Properties

  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No