FDA Registration
Active
🇨🇳 China
Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd.
Reg #: 3007421145
·
FEI: 3004173703
·
Expires 2026
Products
6
Proprietary Names
17
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd.
- Registration Number
- 3007421145
- FEI Number
- 3004173703
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3-6/F, Building 1, 3B/F, 4/F, Building 2, and 5-7/F, Building 3, Rundongsheng Industrial Park, Longteng, Xixiang, Baoan District
- City
- Shenzhen Guangdong
- Country
- CN
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
US Agent
- Business Name
- FLEXTRONICS INTERNATIONAL USA, INC.
- Contact Name
- Chad Ashton
- Address
- 12455 Research Blvd
- City
- Austin
- State
- TX
- ZIP
- 78759
- Country
- US
- [email protected]
- Phone
- 901 8712423
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2016-04-22 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2016-04-22 |
| Sensor, Glucose, Invasive | MDS | Class 3 | Unknown | No | 2016-09-28 |
| Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated | PZE | Class 3 | Unknown | No | 2017-10-11 |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems | QLG | Class 2 | Clinical Chemistry | No | 2020-06-16 |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2025-07-14 |
Proprietary Names
Freestyle Lite Blood Glucose Monitoring System. PRT10500-901 ASSY, METER, MG/DL, USA, CR, FREESTYLE LITE
FREESTYLE LITE BLOOD GLUCOSE MONITO
FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
FreeStyle Precision Neo H Blood Glucose Monitoring System
FreeStyle Libre Pro (System D, PRT29000-506,PRT29000-508, PRT 129000-416
Freestyle Libre Flash Glucose Monitoring System:PRT29000-510 - ASSY, READER, SYSTEM D, MG/DL, 29000, EN-US , GOVT
Freestyle Libre Flash Glucose Monitoring System (System A, PRT22175-123, PRT22175-124, PRT26662-005 (S/A)
Freestyle Libre Flash Glucose Monitoring System:PRT22175-137 - ASSY, READER, SYSTEM A, MG/DL, 22175, EN-US/ES-US, GOVT, NFRS
Freestyle Libre Flash Glucose Monitoring System:PRT22175-135 - ASSY, READER, SYSTEM A, MG/DL, 22175, EN-US/ES-US, GOVT
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
FreeStyle Freedom Lite Blood Glucose Monitoring System
LFR Glucose dehydrogenase, glucose, OTC, Freestyle
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)