FDA Registration
Active
🇨🇳 China
JIANGXI MEDEX TECHNOLOGY CO.,LTD
Reg #: 3013529876
·
FEI: 3013529876
·
Expires 2026
Products
1
Proprietary Names
5
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- JIANGXI MEDEX TECHNOLOGY CO.,LTD
- Registration Number
- 3013529876
- FEI Number
- 3013529876
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ChengXin Avenue,Xinfeng Industrial Area
- City
- Xinfeng Jiangxi
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K980156
Owner / Operator
- Firm Name
- JiangXi Medex Technology Co.,Ltd
- Operator Number
- 10086146
- Address
- ChengXin Avenue,Xinfeng Industrial Area
- City
- Xinfeng
- State
- Jiangxi
- Postal Code
- 330104
- Country
- CN
- Correspondent
- HONG WEI GUO
US Agent
- Business Name
- LLINS TECHNOLOGY INC
- Contact Name
- James Wang
- Address
- 1312 17th St
- City
- Denver
- State
- CO
- ZIP
- 80202
- Country
- US
- [email protected]
- Phone
- 720 2171916
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2022-11-02 |
Proprietary Names
SLT Select Fiber Delivery System and Contact Tips
SACS,Independent Fiber Coolant System
SACSII, Independent Fiber Coolant System
LaserPro Diode Surgical Laser System
Diode Laser System (LaserPro D980, LaserPro D810, Aurolance 980, Aurolance 810, Aurolance AM)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device