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Headgear H4

by Suzhou Yuyue Medical Technology Co., Ltd. 2 variants

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06922166513894 UDI-DI Date30 Sep 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Headgear
Generic Name
Orthodontic chin cap/cup
Model / Ref / Catalog
H4, MA02003
Primary DI / UDI-DI
06922166513894
FDA Product Code
BTK
GMDN Term
Orthodontic chin cap/cup
Device Class
Class I
Regulation Number
868.5560
GUDID distribution status
In Commercial Distribution

Other devices from Suzhou Yuyue Medical Technology Co., Ltd.

See all devices from Suzhou Yuyue Medical Technology Co., Ltd. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No