FDA Registration
Active
🇨🇳 China
SHENZHEN VIVOLIGHT MEDICAL DEVICE&TECHNOLOGY CO., LTD.
Reg #: 3013351723
·
FEI: 3013351723
·
Expires 2026
Products
4
Proprietary Names
13
Establishment Types
1
Classifications
4
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Registration Details
- Registration Name
- SHENZHEN VIVOLIGHT MEDICAL DEVICE&TECHNOLOGY CO., LTD.
- Registration Number
- 3013351723
- FEI Number
- 3013351723
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 511-A, 5th Floor, Block B, Building R2, High-tech Industrial Park, No. 020, South Seventh Road, Gaoxin Community, Yuehai Street, Nanshan District
- City
- shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K242098
Owner / Operator
- Firm Name
- Shenzhen Vivolight Medical Device&Technology Co., Ltd.
- Operator Number
- 10054042
- Address
- Room 511-A, 5th Floor, Block B, Building R2, High-tech Industrial Park, No. 020, South Seventh Road, Gaoxin Community, Yuehai Street, Nanshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518063
- Country
- CN
- Correspondent
- Pengyang Gao
US Agent
- Business Name
- Hlongmed International Ltd.
- Contact Name
- Anny zhao
- Address
- 1312 17th Street#692 Denver, CO 80202
- City
- Denver
- State
- CO
- ZIP
- 80202
- Country
- US
- [email protected]
- Phone
- 503 3344880
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Microscope, Surgical, General & Plastic Surgery | FSO | Class 1 | General, Plastic Surgery | No | 2024-01-25 |
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | Class 2 | Radiology | No | 2025-05-18 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2025-05-18 |
| Device, Vein Location, Liquid Crystal | KZA | Class 1 | General Hospital | No | 2017-02-06 |
Proprietary Names
MICROSCOPE, SURGICAL, Vglasses Pro Vessel navigation glasses
MICROSCOPE, SURGICAL, Vglasses A Vessel navigation glasses
MICROSCOPE, SURGICAL, Vglasses V Vessel navigation glasses
LumenCross Imaging Catheter (F2)
Cornaris Intravascular Imaging System (Mobile-E)
Cornaris Intravascular Imaging System (P80-E)
V900F Projection Vein Finder
V900P Projection Vein Finder
Vivo 500S Projection Vein Finder
V800F Projection Vein Finder
V800P Projection Vein Finder
V800NV Projection Vein Finder
SV800P Projection Vein Finder
Establishment Types
Manufacture Medical Device