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eBcarryon LS-01

by Visgeneer, Inc.

eBcarryon LS-01 is a glucose monitoring system IVD (FDA Class II; FDA product code CGA, Glucose Oxidase, Glucose) made by Visgeneer, Inc., cleared under FDA 510(k) K091765 on 19 Jan 2010 and listed in FDA GUDID since 17 Apr 2026 (UDI-DI 04712558769167), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K091765

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04712558769167 UDI-DI Date17 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK091765 Date19 Jan 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091765 decided 19 Jan 2010 Active
  • FDA GUDID UDI-DI 04712558769167 listed 17 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K091765
  2. Listed FDA GUDID 04712558769167

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
eBcarryon
Generic name
Glucose monitoring system IVD, home-use
Model / reference
LS-01
Primary DI / UDI-DI
04712558769167
510(k) Number
FDA product code
CGA
GMDN term
Glucose monitoring system IVD, home-use
Device class
Class II
Regulation number
862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K091765)

Similar devices

Other devices filed under FDA product code CGA (Glucose Oxidase, Glucose).

Other devices from Visgeneer, Inc.

See all devices from Visgeneer, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)