FDA Registration
Active
🇨🇳 China
SHANGHAI SANYOU MEDICAL CO. LTD
Reg #: 3011556898
·
FEI: 3011556898
·
Expires 2026
Products
6
Proprietary Names
8
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- SHANGHAI SANYOU MEDICAL CO. LTD
- Registration Number
- 3011556898
- FEI Number
- 3011556898
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 385 Huirong Rd, Jiading District,
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K131512
Owner / Operator
- Firm Name
- Shanghai Sanyou Medical Co. LTD
- Operator Number
- 10048121
- Address
- 385 Huirong Rd, Jiading District,
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201815
- Country
- CN
- Correspondent
- David Fan
US Agent
- Business Name
- MRC Global
- Contact Name
- Christine Scifert
- Address
- 9085 East Mineral Circle, Suite 110
- City
- Centennial
- State
- CO
- ZIP
- 80112
- Country
- US
- [email protected]
- Phone
- 901 8318053
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2014-12-10 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2017-12-20 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2017-12-20 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-12-06 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2017-07-24 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2017-07-24 |
Proprietary Names
Katia System
Shanghai Sanyou PEEK Cage System
Duetto
CLIF
Shanghai Sanyou CARMEN Cervical Fusion System
Adena-Zina
Zeus
Keystone/Halis/Dica/Lydia
Establishment Types
Manufacture Medical Device