FDA Registration
Active
🇨🇳 China
Wire, guide, catheterTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCYTRANSDUCER, PRESSURE, CATHETER TIP
Reg #: 3017961114
·
FEI: 3017961114
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SUZHOU PROSTERI MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3017961114
- FEI Number
- 3017961114
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 766 Nanxiang Rd., Wujiang Economic and Technological Development Zone
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K113584
Owner / Operator
- Firm Name
- Suzhou ProSteri Medical Technology Co., Ltd.
- Operator Number
- 10079556
- Address
- 766 Nanxiang Rd., Wujiang Economic and Technological Development Zone
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215200
- Country
- CN
- Correspondent
- Charles Shen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2020-12-11 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2020-12-11 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2020-12-11 |
Proprietary Names
Wire, guide, catheterTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCYTRANSDUCER, PRESSURE, CATHETER TIP
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)