FDA Registration
Active
🇨🇳 China
FUSSEN TECHNOLOGY CO., LTD
Reg #: 3018999255
·
FEI: 3018999255
·
Expires 2026
Products
3
Proprietary Names
6
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- FUSSEN TECHNOLOGY CO., LTD
- Registration Number
- 3018999255
- FEI Number
- 3018999255
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 901,1001, Building #D1, Nanshan Zhiyuan, 1001 Xueyuan Avenue, Changyuan Community, Taoyuan Street, Nanshan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K192766
Owner / Operator
- Firm Name
- Fussen Technology Co., Ltd
- Operator Number
- 10081508
- Address
- 901,1001, Building #D1, Nanshan Zhiyuan, 1001 Xueyuan Avenue, Changyuan Community, Taoyuan Street, Nanshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518055
- Country
- CN
- Correspondent
- registration registration
US Agent
- Business Name
- SHARE INFO INC.
- Contact Name
- Clare Ho
- Address
- 3557 158th St
- City
- Flushing
- State
- NY
- ZIP
- 11358
- Country
- US
- [email protected]
- Phone
- 929 4102964
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2021-04-21 |
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2024-09-05 |
| X-Ray, Tomography, Computed, Dental | OAS | Class 2 | Radiology | No | 2025-11-20 |
Proprietary Names
Fussen, Digital Intraoral Scanner System S6000
Fussen, Digital Intraoral Scanner System S6500
Fussen, Digital Intraoral Scanner System S7000 S7000 Premium
Fussen,Digital Intraoral Scanner System S10
Digital Intraoral Imaging Plate System
Dental Computed Tomography X-ray System
Establishment Types
Manufacture Medical Device