Identity
- Trade Name
- FondCircle FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- Blood Glucose Test Strips Kit FDA UDI
- Model / Reference
- M1-SL50 FDA UDI
- Description
- Blood Glucose Test Strips Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850070979207 FDA UDI
- FDA Product Code
- NBW FDA UDIQRL FDA UDI
- GMDN Term
- Glucose monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI878.4850 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-useBlood lancing device tip
FondCircle by FondCircle Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood lancing device tip.
- CareLiving — CARE LIVING DIAGNOSTICS INC · Class II
- PremierPro Lancet — SVS LLC · Class II
- Accu-Chek Fastclix — ROCHE DIABETES CARE, INC. · Class II
- metene — Tianjin Huahong Technology Co., Ltd. · Class II
- Care Touch — Tianjin Huahong Technology Co., Ltd. · Class II
- H.E.B. inControl — H. E. BUTT GROCERY COMPANY · Class II
- Accu-Chek Safe-T-Pro — ROCHE DIABETES CARE, INC. · Class II
- Accu-Chek Fastclix — ROCHE DIABETES CARE, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FondCircle Inc.
Sources (1)
- FDA UDI 392f262f-3082-4fba-9a7f-42c7fdd07feb 33 fields · synced Jun 6, 2026