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Oticon 219645

by Oticon A/S

Oticon 219645 is a hearing aid/implant system remote control (FDA Class II) made by Oticon A/S, listed in FDA GUDID since 11 May 2020 (UDI-DI 05707131395474), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05707131395474 UDI-DI Date11 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Oticon
Generic name
Hearing aid/implant system remote control
Model / reference
219645
Primary DI / UDI-DI
05707131395474
FDA product code
KLW, OSM
GMDN term
Hearing aid/implant system remote control
Device class
Class II
Regulation number
874.3400, 874.3305
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Hearing aid/implant system remote control

Similar devices in this category

Other devices filed under Hearing aid/implant system remote control.

Other devices from Oticon A/S

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)