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Unitron 050-5781-P8

by Unitron Hearing Division

Unitron 050-5781-P8 is a Class II device made by Unitron Hearing Division, listed in FDA GUDID since 10 Dec 2018 (UDI-DI 07630034393675), 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 Number07630034393675 UDI-DI Date10 Dec 2018ListedStatusListed 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  • Withdrawn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
Unitron
Generic name
Air-conduction hearing aid, behind-the-ear
Model / Ref / Catalog
050-5781-P8
Primary DI / UDI-DI
07630034393675
FDA product code
KLW, OSM
GMDN term
Air-conduction hearing aid, behind-the-ear
Device class
Class II
Regulation number
874.3400, 874.3305
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Air-conduction hearing aid, behind-the-ear

Similar devices in this category

Other devices filed under Air-conduction hearing aid, behind-the-ear.

Other devices from Unitron Hearing Division

See all devices from Unitron Hearing Division →

Properties

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