b-ONE Medical (Beijing) Co., Ltd.
Registered establishment in Beijing, China. 7 device types.
b-ONE Medical (Beijing) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Screw, Fixation, Bone, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented and 5 other device types. Its earliest product listing with the FDA dates from 2018.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3014644608 |
| FEI number | 3014644608 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 宽岳医疗科技（北京）有限公司 |
|---|---|
| Source | export sales certificate, Beijing medical products administration |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | No.8 West Caixiang Road, Shun Yi district |
| Postal code | 101300 |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class 2 | 2026 | 14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class 2 | 2018 | 15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class 2 | 2024 | 13 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class 2 | 2018 | 14 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class 2 | 2021 | 8 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class 2 | 2018 | 21 |
| Screw, Fixation, Bone | Class 2 | 2018 | 31 |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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