FDA Registration
Active
🇨🇳 China
LINCOTEK (WUXI) CO., LTD.
Reg #: 3021386586
·
FEI: 3021386586
·
Expires 2025
Products
2
Proprietary Names
0
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- LINCOTEK (WUXI) CO., LTD.
- Registration Number
- 3021386586
- FEI Number
- 3021386586
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Block G, No. 30 Wanquan Road, Yunlin, Xishan District
- City
- Wuxi Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K182705
Owner / Operator
- Firm Name
- Lincotek (Wuxi) Co., Ltd.
- Operator Number
- 10083716
- Address
- Block G, No. 30 Wanquan Road, Yunlin, Xishan District
- City
- Wuxi
- State
- Jiangsu
- Postal Code
- 214192
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2021-12-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-12-13 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)