FondCircle FBG-M2
FondCircle FBG-M2 is a Class II device made by FondCircle Inc., listed in FDA GUDID since 14 Jan 2025 (UDI-DI 00850070979047), not in commercial distribution (GUDID) as of 2 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 | Number00850070979047 | Date14 Jan 2025 | StatusListed |
Official records
- AccessGUDID record 00850070979047
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- Withdrawn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
- FBG-M2
- Primary DI / UDI-DI
- 00850070979047
- 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
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