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Fully-Automated Urine Chemistry Analyzer DxU 1800c, 1 unit

by Urit Medical Electronic Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06935740751568 UDI-DI Date26 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Fully-Automated Urine Chemistry Analyzer
Generic Name
Urine analyser IVD, laboratory
Model / Reference
DxU 1800c, 1 unit
Primary DI / UDI-DI
06935740751568
510(k) Number
FDA Product Code
JFY, CDM, CEN, JIL, JIN, KQO, JIO, JIR, JJB, JMA, JMT, LJX, JRE
GMDN Term
Urine analyser IVD, laboratory
Device Class
Class II
Regulation Number
862.1225, 862.1785, 862.1550, 862.1340, 862.1435, 862.2900, 864.6550, 862.1645, 862.1115, 862.1095, 862.1510, 864.7675, 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

  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • 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