Identity
- Trade Name
- FondCircle FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- Blood Glucose Monitoring FDA UDI
- Model / Reference
- M1 FDA UDI
- Description
- Blood Glucose Monitoring FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850070979238 FDA UDI
- 510(k) Number
- K191657 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Glucose monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glucose monitoring system IVD, home-use
FondCircle by FondCircle Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glucose monitoring system IVD, home-use.
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Cleared under the same submission
K191657 also covers:
- Andnesfit Health — ANDESFIT LIMITED
- COLEBY — Bioland Technology Ltd.
- DKK — Bioland Technology Ltd.
- ELERA — Bioland Technology Ltd.
- ELERA — Bioland Technology Ltd.
- FitPeo — Bioland Technology Ltd.
- Wellue — Bioland Technology Ltd.
- Wellue — Bioland Technology Ltd.
- bioland — Bioland Technology Ltd.
- telli health — Bioland Technology Ltd.
- telli health — Bioland Technology Ltd.
- FondCircle — FondCircle Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- FondCircle Inc.
Sources (1)
- FDA UDI b0066917-58f2-4c0b-b81e-dad2d7c1acce 34 fields · synced May 30, 2026