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Na 5380966

by GE Hangwei Medical Systems Company 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682102674 UDI-DI Date28 Jul 2017ListedStatusListed 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  • Withdrawn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
CT system table
Model / Reference
5380966
Primary DI / UDI-DI
00840682102674
FDA Product Code
IZZ
GMDN Term
CT system table
Device Class
Class II
Regulation Number
892.1980
GUDID distribution status
In Commercial Distribution

Related devices

Category: CT system table

Other devices from GE Hangwei Medical Systems Company Ltd.

See all devices from GE Hangwei Medical Systems Company Ltd. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No