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Hygitech Hy-301

by Hygitech

Hygitech Hy-301 is a Class I device made by Hygitech, listed in FDA GUDID since 15 Dec 2020 (UDI-DI 03615140000420), 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 Number03615140000420 UDI-DI Date15 Dec 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  • Withdrawn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
Hygitech
Generic name
Moist-cold pack
Model / Ref / Catalog
HY-301
Primary DI / UDI-DI
03615140000420
FDA product code
IMD
GMDN term
Moist-cold pack
Device class
Class I
Regulation number
890.5710
GUDID distribution status
In Commercial Distribution

Related devices

Category: Moist-cold pack

Similar devices

Other devices filed under FDA product code IMD (Pack, Hot Or Cold, Disposable).

Other devices from Hygitech

See all devices from Hygitech →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)