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Widex RC4

by Widex A/S 12 variants

Widex RC4 (8 038 0100 080) is a hearing aid/implant system remote control (FDA Class I; FDA product code ESD, Hearing Aid, Air Conduction) made by Widex A/S, listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05706069305067), 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 Number05706069305067 UDI-DI Date1 Sep 2016ListedStatusListed 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  • Withdrawn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
Widex
Generic name
Hearing aid/implant system remote control
Model / Ref / Catalog
RC4, 8 038 0100 080
Primary DI / UDI-DI
05706069305067
FDA product code
ESD
GMDN term
Hearing aid/implant system remote control
Device class
Class I
Regulation number
874.3300
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

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 Widex A/S

See all devices from Widex A/S →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)