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Usmile 3000008

by Guangzhou Stars Pulse 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 Number00817277020927 UDI-DI Date5 Oct 2025ListedStatusListed 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  • Withdrawn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
Usmile
Generic Name
Oral lavage system
Model / Reference
3000008
Primary DI / UDI-DI
00817277020927
FDA Product Code
EFS
GMDN Term
Oral lavage system
Device Class
Class I
Regulation Number
872.6510
GUDID distribution status
In Commercial Distribution

Other devices from Guangzhou Stars Pulse Co., Ltd.

See all devices from Guangzhou Stars Pulse Co., Ltd. →

Properties

  • Premarket Exempt
  • 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
  • Lot / Batch Number: No