FDA Registration
Active
🇨🇳 China
REGENT ELECTRON SUZHOU CO., LTD
Reg #: 3012404027
·
FEI: 3012404027
·
Expires 2026
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- REGENT ELECTRON SUZHOU CO., LTD
- Registration Number
- 3012404027
- FEI Number
- 3012404027
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.888.Ganquan Dong Road, Economic development zone
- City
- Wujiang Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Regent Electron Suzhou Co., Ltd
- Operator Number
- 10051810
- Address
- NO.888.Ganquan Dong Road, Economic development zone,
- City
- Wujiang
- State
- Jiangsu
- Postal Code
- 215200
- Country
- CN
US Agent
- Business Name
- ROC Chinese-European Industrial Research Society
- Contact Name
- Shu-Chen Cheng
- Address
- 2064 Tamarin Dr
- City
- Columbus
- State
- OH
- ZIP
- 43235
- Country
- US
- [email protected]
- Phone
- 614 5888168
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2020-02-28 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2026-06-10 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2026-06-10 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-01-10 |
| Scale, Stand-On, Patient | FRI | Class 1 | General Hospital | No | 2016-06-07 |
Proprietary Names
WBS15
Scan Monitor (ScanWatch, hwa09; ScanWatch 2, hwa10)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)