FDA Registration
Active
🇨🇳 China
CANWELL MEDICAL CO., LTD.
Reg #: 3006395932
·
FEI: 3006395932
·
Expires 2025
Products
13
Proprietary Names
0
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- CANWELL MEDICAL CO., LTD.
- Registration Number
- 3006395932
- FEI Number
- 3006395932
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 466, South Xianhua Street.,, High-Tech Industrial Zone,
- City
- Jinhua Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K123598
Owner / Operator
- Firm Name
- Canwell Medical Co., Ltd.
- Operator Number
- 10024685
- Address
- No. 466, South Xianhua Street.,, High-Tech Industrial Zone,
- City
- Jinhua
- State
- Zhejiang
- Postal Code
- 321016
- Country
- CN
- Correspondent
- Ming Fang
US Agent
- Business Name
- LLINS TECHNOLOGY INC
- Contact Name
- James Wang
- Address
- 1312 17th St Pmb 2199
- City
- Denver
- State
- CO
- ZIP
- 80202
- Country
- US
- [email protected]
- Phone
- 720 2171916
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2019-12-09 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2019-12-09 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2019-12-09 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2019-12-09 |
| Mesh, Surgical, Acetabular, Hip, Prosthesis | JDJ | Class 2 | General, Plastic Surgery | No | 2019-12-09 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2019-12-09 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2019-12-09 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2019-12-09 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2019-12-09 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2019-12-09 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2019-12-09 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2019-12-09 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | LZY | Class 2 | Orthopedic | No | 2019-12-09 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)