FDA Registration
Active
🇨🇳 China
Pediatric Head-Spine Coil (4522-150-41161)
Reg #: 3012439308
·
FEI: 3012439308
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHANGHAI CHENSHI MEDICAL INSTRUMENTS CO., LTD
- Registration Number
- 3012439308
- FEI Number
- 3012439308
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 206-207, Floor 2, Building 3, No. 8 of Area 3, No. 8228, Beiqing Road, Qingpu District
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K081322
Owner / Operator
- Firm Name
- Shanghai Chenshi Medical Instruments Co., Ltd
- Operator Number
- 10058646
- Address
- Room 206-207, Floor 2, Building 3, No. 8 of Area 3, No. 8228, Beiqing Road, Qingpu District
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201700
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2018-10-17 |
Proprietary Names
Pediatric Head-Spine Coil (4522-150-41161)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device