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MyGlucoHealth® Test Strips MGH-TS50

by Entra Health Systems

Listed FDA GUDID listing, not in commercial distribution

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 Number00850081003014 UDI-DI Date27 Jan 2017ListedStatusListed GUDID: not 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  • Withdrawn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
MyGlucoHealth® Test Strips
Generic Name
Glucose IVD, kit, electrometry
Model / Reference
MGH-TS50
Primary DI / UDI-DI
00850081003014
FDA Product Code
CGA
GMDN Term
Glucose IVD, kit, electrometry
Device Class
Class II
Regulation Number
862.1345
GUDID distribution status
Not in Commercial Distribution
Size
Total Volume — 0.3 Microliter

Other devices from Entra Health Systems

Properties

  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No