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audifon saga R TRT

by audifon GmbH & Co. KG 9 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 NumberEADF022234855231317201 UDI-DI Date18 Nov 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
audifon
Generic Name
Air-conduction hearing aid, receiver-in-canal
Model / Ref / Catalog
saga R TRT, 022234-8552-313-1720
Primary DI / UDI-DI
EADF022234855231317201
510(k) Number
FDA Product Code
KLW, ESD
GMDN Term
Air-conduction hearing aid, receiver-in-canal
Device Class
Class II
Regulation Number
874.3400, 874.3300
GUDID distribution status
Not in Commercial Distribution

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

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