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GluLink

by HeYuan FandDing Medical Co Ltd

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 21 Oct 2026. What this means

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06975640490013 UDI-DI Date17 Nov 2022ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Rapid test/self-testing data interpretive/transfer/validation software IVD
Model / Reference
/
Primary DI / UDI-DI
06975640490013
FDA Product Code
OUG
GMDN Term
Rapid test/self-testing data interpretive/transfer/validation software IVD
Device Class
Class I
Regulation Number
880.6310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rapid test/self-testing data interpretive/transfer/validation software IVD

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • 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
  • Expiration Date: No