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audifon saga R TRT

by audifon GmbH & Co. KG GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEADF0222348552338217201 UDI-DIDate18 Nov 2016ListedStatusListed GUDID: not 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  • Withdrawn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 23 Oct 2026.

Specification

GUDID

Trade Name
audifon
Generic Name
Air-conduction hearing aid, receiver-in-canal
Model / Ref / Catalog
saga R TRT, 022234-8552-3382-1720
Primary DI / UDI-DI
EADF0222348552338217201
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