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Be Smart Blood Glucose Meter

by Eps Bio Technology Corp.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number06225000563858 UDI-DI Date7 May 2026ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Glucose monitoring system IVD, home-use
Model / Reference
Be Smart
Primary DI / UDI-DI
06225000563858
510(k) Number
FDA Product Code
NBW
GMDN Term
Glucose monitoring system IVD, home-use
Device Class
Class II
Regulation Number
862.1345
GUDID distribution status
Not in Commercial Distribution

Other devices from Eps Bio Technology Corp.

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Properties

  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number
  • 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
  • Expiration Date: No