Shenzhen Sophway Technology Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 3 device types, 2 clearances.
Shenzhen Sophway Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Led Light Source, Laparoscope, General & Plastic Surgery and 1 other device type. Its earliest product listing with the FDA dates from 2025.
3device types registered with the FDA
2510(k) clearances
Registration
| Registered name | SHENZHEN SOPHWAY TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3043152784 |
| FEI number | 3043152784 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳术为科技有限公司 |
|---|---|
| Unified social credit code | 91440300MA5FM3403F |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | A1301A, Building 1, Meixun Digital Technology Factory, No. 19 Jinxiu Middle Road |
| Postal code | 518122 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Class 2 | Endoscopic Camera System (SV-300, SV-300I, SV-300R, SV-300N) | 2025 | 8 |
| Laparoscope, General & Plastic Surgery | Class 2 | 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) | 2025 | 46 |
| Led Light Source | Class 2 | Endoscopic LED Light Source (SL-200, SL-200N) | 2025 | 11 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K250551 | 2025-10-02 | GCJ | Traditional | This company |
| K250204 | 2025-07-01 | FET | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2019 |
|---|---|
| Main products | 4K endoscopic camera systems, optical endoscopes, endoscopy systems, insufflators, peripheral endoscopy devices |
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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