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Detergent Concentrated DxU, 1×500mL

by Urit Medical Electronic Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number06935740751674 UDI-DI Date26 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Detergent Concentrated
Generic Name
Instrument/analyser cleaning agent IVD
Model / Reference
DxU, 1×500mL
Primary DI / UDI-DI
06935740751674
FDA Product Code
JCB
GMDN Term
Instrument/analyser cleaning agent IVD
Device Class
Class I
Regulation Number
864.4010
GUDID distribution status
In Commercial Distribution

Other devices from Urit Medical Electronic Co., Ltd.

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

Properties

  • Premarket Exempt
  • Lot / Batch 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
  • Serial Number: No