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Hygitech Hy-609

by Hygitech

Hygitech Hy-609 is a Class II device made by Hygitech, listed in FDA GUDID since 25 Nov 2020 (UDI-DI 03615140003698), 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 Number03615140003698 UDI-DI Date25 Nov 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  • Withdrawn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
Surgical dressing/drape kit, single-use
Model / Ref / Catalog
HY-609
Primary DI / UDI-DI
03615140003698
FDA product code
KKX
GMDN term
Surgical dressing/drape kit, single-use
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code KKX (Drape, Surgical).

Other devices from Hygitech

See all devices from Hygitech →

Properties

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