FondCircle VGM04
FondCircle VGM04 is a Class II device made by FondCircle Inc., listed in FDA GUDID since 26 Oct 2026 (UDI-DI 00850070979351), registry data as of 9 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850070979351 | Date26 Oct 2026 | StatusListed |
Official records
- AccessGUDID record 00850070979351
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- FondCircle
- Generic name
- Glucose monitoring system IVD, home-use
- Model / reference
- VGM04
- Primary DI / UDI-DI
- 00850070979351
- FDA product code
- NBW
- GMDN term
- Glucose monitoring system IVD, home-use
- Device class
- Class II
- Regulation number
- 862.1345
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NBW (System, Test, Blood Glucose, Over The Counter).
- OneTouch Ultra Blue Test Strips 024-273 by LifeScan U.S. LLC
- ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL by Bayer Corp.
- CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER by i-SENS, Inc.
- POPS! one Blood Glucose Monitoring System by TAIDOC TECHNOLOGY CORPORATION
- MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS by Entra Health Systems
- EASYGLUCO, MODEL IGM0002 by American Healthcare, Inc.
- EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009 by EPS BIO TECHNOLOGY CORP.
- TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS by Home Diagnostics, Inc.
- EZ SMART by Vip International Wholesalers, Corp.
- ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM by Broadmaster Biotech Corperation