Shenzhen Vivolight Medical Device&Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 4 device types, 3 products catalogued, 1 clearance.
Shenzhen Vivolight Medical Device&Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Catheter, Intravascular, Diagnostic, Device, Vein Location, Liquid Crystal and 2 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
Registration
| Registered name | SHENZHEN VIVOLIGHT MEDICAL DEVICE&TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013351723 |
| FEI number | 3013351723 |
| DUNS | 543028475 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市中科微光医疗器械技术有限公司 |
|---|---|
| Unified social credit code | 91440300052779108W |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Room 511-A, 5th Floor, Block B, Building R2, High-tech Industrial Park, No. 020, South Seventh Road |
| Postal code | 518063 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | Class 2 | Cornaris Intravascular Imaging System (P80-E), Cornaris Intravascular Imaging System (Mobile-E), LumenCross Imaging Catheter (F2) | 2025 | 11 |
| Device, Vein Location, Liquid Crystal | Class 1 | Vivo 500S Projection Vein Finder, V800F Projection Vein Finder, V800NV Projection Vein Finder, V800P Projection Vein Finder, SV800P Projection Vein Finder, V900P Projection Vein Finder and 1 more | 2017 | 10 |
| Microscope, Surgical, General & Plastic Surgery | Class 1 | MICROSCOPE, SURGICAL, Vglasses V Vessel navigation glasses, MICROSCOPE, SURGICAL, Vglasses A Vessel navigation glasses, MICROSCOPE, SURGICAL, Vglasses Pro Vessel navigation glasses | 2024 | 11 |
| System, Imaging, Optical Coherence Tomography (Oct) | Class 2 | Cornaris Intravascular Imaging System (P80-E), Cornaris Intravascular Imaging System (Mobile-E), LumenCross Imaging Catheter (F2) | 2025 | 2 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Cornaris Intravascular Imaging System | NQQ | 2 |
| Veincas | KZA | 1 |
| LumenCross Imaging Catheter | DQO | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242098 | 2025-04-11 | NQQ | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Main products | Intravascular OCT Imaging System, Laser Atherectomy System, Vessel Visualization System, Vein Locator devices |
| Certifications | FDA clearance, NMPA approval for FastErazer system |
| Export markets | Peru, Brazil, Australia, global presence |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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