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Hansaton 050-6022-U8

by Hansaton Akustik GmbH

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 Number04250185559152 UDI-DI Date10 Dec 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  • Withdrawn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
Hansaton
Generic name
Air-conduction hearing aid, receiver-in-canal
Model / Ref / Catalog
050-6022-U8
Primary DI / UDI-DI
04250185559152
FDA product code
OSM, KLW
GMDN term
Air-conduction hearing aid, receiver-in-canal
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, receiver-in-canal

Other devices from Hansaton Akustik GmbH

See all devices from Hansaton Akustik GmbH →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: 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
  • Expiration date: No