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Utk H41K1

by Utk Technology(Shenzhen)Limited

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 Number06970663420771 UDI-DI Date18 Jun 2026ListedStatusListed 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  • Withdrawn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
Utk
Generic Name
Electric pad localized-body heating system
Model / Reference
H41K1
Primary DI / UDI-DI
06970663420771
FDA Product Code
IRT
GMDN Term
Electric pad localized-body heating system
Device Class
Class II
Regulation Number
890.5740
GUDID distribution status
In Commercial Distribution

Other devices from Utk Technology(Shenzhen)Limited

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Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No