FDA Registration
Active
🇨🇳 China
GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.
Reg #: 3029968414
·
FEI: 3029968414
·
Expires 2026
Products
7
Proprietary Names
21
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.
- Registration Number
- 3029968414
- FEI Number
- 3029968414
- Status
- Active
- Expiry Year
- 2026
- 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
- K241530
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 | 2024-08-13 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2023-10-13 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2023-10-13 |
| Laparoscope And Accessories, Gynecologic, Reprocessed | NMH | Class 2 | Obstetrics/Gynecology | No | 2023-10-13 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2023-10-13 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2024-10-29 |
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2023-10-13 |
Proprietary Names
Stellar Light Source: SL20
Stellar Camera Head: SC10E
Stellar Image Processing Unit: SI10E
3D Laparoscope: 21033SA,21033SC
Stellar Light Source: SL10
Stellar Exoscope: 31103FA
Stellar Fluorescence Camera Head: SC20E
Stellar 3D Fluorescence Camera Head: SC20D
Stellar 3D Camera Head: SC10D
Insufflator OPTO-IFL1000
Light Source OPTO-LED104K
3D Laparoscope: 21050SA, 21050SC
Laparoscope 21033FA, 21033FC, 21033WA, 21033WC, 20533WA, 20533WC, 20533FA, 20533FC
FloNavi Endoscopic Fluorescence Imaging System OPTO-CAM2100, OPTO-CHD2100, OPTO-LED2100
FloNavi Endoscopic Fluorescence Imaging System OPTO-CAM214K, OPTO-CHD214KE, OPTO-CHD214KH, OPTO-LED214K
Endoscopic Fluorescence lmaging System 71-182-30 NIR, 71-068-05 NIR, 71-068-10 NIR, 71-068-20 NIR
Endoscopic Fluorescence lmaging System 71-068-05 NIR-CA, 71-068-10 NIR-CA, 71-068-20 NIR-CA,71-182-30 NIR-CA
Endoscopic Camera System OPTO-CAM104K, OPTO-CHD104KH
FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)
Insufflator
FloNavi Open Field Fluorescence Imaging System OPTO-CAM2100, OPTO-CHD3100H, OPTO-CHD3100E, OPTO-CAM214K, OPTO-CHD314KE
Establishment Types
Manufacture Medical Device