FDA Registration
Active
🇨🇳 China
b-ONE Medical (Beijing) Co., Ltd.
Reg #: 3014644608
·
FEI: 3014644608
·
Expires 2026
Products
7
Proprietary Names
0
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- b-ONE Medical (Beijing) Co., Ltd.
- Registration Number
- 3014644608
- FEI Number
- 3014644608
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.8 West Caixiang Road, Shun Yi district
- City
- Beijing
- Country
- CN
Owner / Operator
- Firm Name
- b-ONE Medical (Beijing) Co., Ltd.
- Operator Number
- 10058218
- Address
- No.8 West Caixiang Road, Shun Yi district
- City
- Beijing
- State
- CN-BJ
- Postal Code
- 101300
- Country
- CN
- Correspondent
- Zhou He
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2021-10-05 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2022-08-03 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2021-10-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-10-05 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-12-04 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2026-06-04 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2024-12-10 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)