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Agxo 193316

by Oticon 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05707131341167 UDI-DI Date20 Aug 2018ListedStatusListed 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  • Withdrawn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
Agxo
Generic name
Air-conduction hearing aid, behind-the-ear
Model / reference
193316
Primary DI / UDI-DI
05707131341167
FDA product code
OSM, KLW
GMDN term
Air-conduction hearing aid, behind-the-ear
Device class
Class II
Regulation number
874.3305, 874.3400
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

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

Other devices from Oticon A/S

See all devices from Oticon A/S →

Properties

  • Prescription use
  • Serial number

Other properties (13)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No
  • Expiration date: No
  • Manufacturing date: No