FDA Registration
Active
🇺🇸 United States
Flextronics America, LLC
Reg #: 3006537560
·
FEI: 3006537560
·
Expires 2026
Products
3
Proprietary Names
7
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Flextronics America, LLC
- Registration Number
- 3006537560
- FEI Number
- 3006537560
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 12455 Research Boulevard
- City
- Austin
- State
- TX
- ZIP
- 78759
- Country
- US
Owner / Operator
- Firm Name
- Flextronics International USA, Inc.
- Operator Number
- 9006592
- Address
- 12455 Research Blvd
- City
- Austin
- State
- TX
- Postal Code
- 78759
- Country
- US
- Correspondent
- Chad Ashton
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems | QLG | Class 2 | Clinical Chemistry | No | 2022-05-27 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2023-09-19 |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2023-09-19 |
Proprietary Names
FreeStyle Libre 3 Continuous Glucose Monitoring System
FreeStyle Libre 2 Flash Glucose Monitoring System
FreeStyle Libre 3 Reader Kits
FreeStyle Libre 2 Reader Kits
Instinct Sensor
FreeStyle Libre 2 Plus Sensor Kits
FreeStyle Libre 3 Plus Sensor Kits
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only