FDA Registration
Active
🇨🇳 China
SHENZHEN SOPHWAY TECHNOLOGY CO., LTD.
Reg #: 3043152784
·
FEI: 3043152784
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SHENZHEN SOPHWAY TECHNOLOGY CO., LTD.
- Registration Number
- 3043152784
- FEI Number
- 3043152784
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- A1301A, Building 1, Meixun Digital Technology Factory, No. 19 Jinxiu Middle Road, Laokeng Community, Longtian Street, Pingshan District,
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K250204
Owner / Operator
- Firm Name
- Shenzhen Sophway Technology Co., Ltd.
- Operator Number
- 10094859
- Address
- A1301A, Building 1, Meixun Digital Technology Factory, No. 19 Jinxiu Middle Road, Laokeng Community, Longtian Street, Pingshan District,
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518122
- Country
- CN
- Correspondent
- Vivian Liu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2025-12-30 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2025-12-30 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2025-12-30 |
Proprietary Names
Endoscopic LED Light Source (SL-200, SL-200N)
Endoscopic Camera System (SV-300, SV-300I, SV-300R, SV-300N)
4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
Establishment Types
Manufacture Medical Device