FDA Registration
Active
🇰🇷 South Korea
Dexcam3
Reg #: 3007518359
·
FEI: 3007518359
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- WINUS TECHNOLOGY CO., LTD.
- Registration Number
- 3007518359
- FEI Number
- 3007518359
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5F, 298-7, Gongdan-ro
- City
- Gun Po Si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K040691
Owner / Operator
- Firm Name
- WinUs Technology Co., Ltd.
- Operator Number
- 10028427
- Address
- 5F,298-7, Gongdan-ro
- City
- Gun Po Si
- State
- Gyeonggi
- Postal Code
- 435862
- Country
- KR
- Correspondent
- Gee H Lee
US Agent
- Business Name
- WinUs Technology Co., Ltd.
- Contact Name
- Gee Hae Lee
- Address
- 1926 Crenshaw Circle
- City
- Vernon Hills
- State
- IL
- ZIP
- 60061
- Country
- US
- [email protected]
- Phone
- 224 3875588
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2009-01-29 |
Proprietary Names
Dexcam3
Smartcam
GXC300
Dexcam4
Raycam
Raycam Plus
Dexcam4 HD
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device