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PHONELUM Sara 10

by Shenzhen Eartech 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 Number06974608620523 UDI-DI Date27 Aug 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  • Withdrawn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
Phonelum
Generic Name
Air-conduction hearing aid, in-the-ear
Model / Reference
Sara 10
Primary DI / UDI-DI
06974608620523
FDA Product Code
QUG, OSM
GMDN Term
Air-conduction hearing aid, in-the-ear
Device Class
Class II
Regulation Number
874.3305
GUDID distribution status
In Commercial Distribution

Other devices from Shenzhen Eartech Co., Ltd.

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No
  • Manufacturing Date: No