FDA Registration
Active
🇨🇳 China
B-ONE MEDICAL (SUZHOU) CO., LTD.
Reg #: 3015167917
·
FEI: 3015167917
·
Expires 2026
Products
23
Proprietary Names
0
Establishment Types
1
Classifications
23
Registration Details
- Registration Name
- B-ONE MEDICAL (SUZHOU) CO., LTD.
- Registration Number
- 3015167917
- FEI Number
- 3015167917
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 6 Yuping Road, Science & Technology Town, New District
- City
- Suzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- b-ONE Medical (Suzhou) Co., Ltd.
- Operator Number
- 10059535
- Address
- No. 6 Yuping Road, Science & Technology Town, New District
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215163
- 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 | 2022-02-09 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2019-01-30 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-04-13 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2021-04-13 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2020-09-01 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2019-01-30 |
| Corkscrew | HWI | Class 1 | Orthopedic | No | 2019-01-31 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2019-01-30 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-01-31 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-01-30 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2019-01-30 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2019-01-30 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2019-01-30 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2022-11-18 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2019-01-30 |
| Template | HWT | Class 1 | Orthopedic | No | 2019-01-30 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2019-01-30 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2019-01-30 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2026-06-04 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2019-01-30 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2019-01-31 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2019-01-30 |
| 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)