FDA Registration
Active
🇺🇸 United States
FreeStyle Libre 2 Flash Glucose Monitoring System
Reg #: 3011536730
·
FEI: 3011536730
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Flextronics International USA
- Registration Number
- 3011536730
- FEI Number
- 3011536730
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 700 Corporate Grove Drive
- City
- Buffalo Grove
- State
- IL
- ZIP
- 60089
- Country
- US
Owner / Operator
- Firm Name
- Flextronics International USA, Inc.
- Operator Number
- 9006592
- Address
- 6201 America Center Drive
- City
- San Jose
- State
- CA
- Postal Code
- 95002
- Country
- US
- Correspondent
- Chad Ashton
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2020-03-30 |
Proprietary Names
FreeStyle Libre 2 Flash Glucose Monitoring System
Establishment Types
Manufacture Device in the United States for Export Only