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Neutral 228203

by Sbo Hearing A/S

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 Number05714464012879 UDI-DI Date6 Aug 2021ListedStatusListed 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  • Withdrawn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
Neutral
Generic Name
Hearing aid/implant system remote control
Model / Reference
228203
Primary DI / UDI-DI
05714464012879
FDA Product Code
OSM, KLW
GMDN Term
Hearing aid/implant system remote control
Device Class
Class II
Regulation Number
874.3305, 874.3400
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Sbo Hearing A/S

See all devices from Sbo Hearing A/S →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No