Skip to content

HighLight HMNE-4500

by Hatchmed Corporation

HighLight HMNE-4500 is a Class II device made by Hatchmed Corporation, listed in FDA GUDID since 15 May 2026 (UDI-DI 00850042446546), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850042446546 UDI-DI Date15 May 2026ListedStatusListed 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  • Withdrawn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
HighLight
Generic name
Pillow speaker
Model / Ref / Catalog
HMNE-4500
Primary DI / UDI-DI
00850042446546
FDA product code
ILQ
GMDN term
Pillow speaker
Device class
Class II
Regulation number
890.3710
GUDID distribution status
In Commercial Distribution

Other devices from Hatchmed Corporation

See all devices from Hatchmed Corporation →

Properties

  • Premarket exempt
  • Manufacturing date
Other properties (13, all answered No)