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Healthisound JH-A17BT

by Enticare P.C. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860013064044 UDI-DIDate27 Nov 2024ListedStatusListed 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  • Withdrawn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
Healthisound
Generic Name
Air-conduction hearing aid, in-the-ear
Model / Reference
JH-A17BT
Primary DI / UDI-DI
00860013064044
FDA Product Code
QUF
GMDN Term
Air-conduction hearing aid, in-the-ear
Device Class
Class I
Regulation Number
874.3300
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: Air-conduction hearing aid, in-the-ear

Properties

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