FDA Registration
Active
🇨🇳 China
FloNavi Open Field Fluorescence Imaging System OPTO-CAM2100, OPTO-CHD3100H, OPTO-CHD3100E, OPTO-CAM214K, OPTO-CHD314KE
Reg #: 3029968414
·
FEI: 3029968414
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.
- Registration Number
- 3029968414
- FEI Number
- 3029968414
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Suite 503, Building A, Golden Valley Intellicreation Community, No. 2 Yonganbei Street, Daxu, Guicheng,Nanhai
- City
- Foshan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K230407
Owner / Operator
- Firm Name
- Guangdong OptoMedic Technologies, Inc.
- Operator Number
- 10088815
- Address
- Suite 503, Building A, Golden Valley Intellicreation Community,, No. 2 Yonganbei Street, Daxu, Guicheng,Nanhai
- City
- Foshan
- State
- Guangdong
- Postal Code
- 528200
- Country
- CN
- Correspondent
- Kaiyi Liao
US Agent
- Business Name
- Shenzhen Joyantech Consulting Co., Ltd.
- Contact Name
- Thomas Tang
- Address
- 25 Hopewell Drive Stony Brook
- City
- Stony Brook
- State
- NY
- ZIP
- 11790
- Country
- US
- [email protected]
- Phone
- 631 9014608
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-10-13 |
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2023-10-13 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2023-10-13 |
Proprietary Names
FloNavi Open Field Fluorescence Imaging System OPTO-CAM2100, OPTO-CHD3100H, OPTO-CHD3100E, OPTO-CAM214K, OPTO-CHD314KE
Establishment Types
Manufacture Medical Device