FDA Registration
Active
🇨🇳 China
b-ONE Medical (Beijing) Co., Ltd.
Reg #: 3014644608
·
FEI: 3014644608
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- b-ONE Medical (Beijing) Co., Ltd.
- Registration Number
- 3014644608
- FEI Number
- 3014644608
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.8 West Caixiang Road, Shun Yi district
- City
- Beijing
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K180446
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 | 2018-12-04 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)