Skip to content

BLE Smart Test Strip BLE-SMART-TS50-FDA

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10852668007016 UDI-DIDate5 Feb 2019ListedStatusListed 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  • Withdrawn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
BLE Smart Test Strip
Generic Name
Glucose IVD, kit, electrometry
Model / Reference
BLE-SMART-TS50-FDA
Primary DI / UDI-DI
10852668007016
FDA Product Code
LFR
GMDN Term
Glucose IVD, kit, electrometry
Device Class
Class II
Regulation Number
862.1345
GUDID distribution status
Not in Commercial Distribution

Other devices from Entra Health Systems

Properties

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

Other properties (8)

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