FDA Registration
Active
🇨🇳 China
Flextronics Industrial (Shenzhen) Co., Ltd.
Reg #: 3007710663
·
FEI: 3004173703
·
Expires 2026
Products
5
Proprietary Names
16
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Flextronics Industrial (Shenzhen) Co., Ltd.
- Registration Number
- 3007710663
- FEI Number
- 3004173703
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7/F, Building 1, 1/F, 3A/F, 5-7/F, Building 2, and 2-4/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 |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2009-06-29 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2013-09-17 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2009-06-29 |
| Pump, Infusion, Insulin | LZG | Class 2 | General Hospital | No | 2010-07-13 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2014-11-23 |
Proprietary Names
SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
OneTouch UltraSmart Blood Glucose Monitoring System
One Touch Verio Flex Blood Glucose Monitoring System
OneTouch Verio Reflect Blood Glucose Monitoring System
ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
SYMPHONY METER REMOTE
SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
One Touch Verio: Blood Glucose Monitoring System
ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
OneTouch Ultra Plus Flex Blood Glucose Monitoring System
ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
OneTouch Verio Blood Glucose Monitoring System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)