FDA Registration
Active
🇨🇳 China
TureView 100 Pro
Reg #: 3017889703
·
FEI: 3017889703
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- COMPAI HEALTHCARE (SUZHOU) CO.,LTD
- Registration Number
- 3017889703
- FEI Number
- 3017889703
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 3A05, Building 2, No.8 Changting Road,High-tech Zone, Suzhou, Jiangsu, P.R. China
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K202713
Owner / Operator
- Firm Name
- CompAI Healthcare (Suzhou) Co.,ltd
- Operator Number
- 10086645
- Address
- Room 3A05, Building 2, No.8 Changting Road,High-tech Zone, Suzhou, Jiangsu, P.R. China
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215151
- Country
- CN
- Correspondent
- Sheng Peng
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cabinet, X-Ray System | MWP | Class 2 | Radiology | No | 2022-12-19 |
Proprietary Names
TureView 100 Pro
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)