FDA Registration
Active
🇨🇳 China
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
Reg #: 3014302721
·
FEI: 3014302721
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3014302721
- FEI Number
- 3014302721
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building 9, Baiwang Creative Factory, No. 1051, Songbai Road, Xili Street, Nanshan District, 518055 Shenzhen,
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K210154
Owner / Operator
- Firm Name
- Shenzhen Wisonic Medical Technology Co., Ltd.
- Operator Number
- 10056768
- Address
- 5th Floor, NO.6 Building, PingshanTech Park,Taoyuan Street,Nanshan
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518055
- Country
- CN
- Correspondent
- Xiaosan Jiang
US Agent
- Business Name
- Manton Business and Technology Services
- Contact Name
- Charles Shen
- Address
- 37 Winding Ridge
- City
- Oakland
- State
- NJ
- ZIP
- 07436
- Country
- US
- [email protected]
- Phone
- 608 2179358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Biopsy Needle Guide Kit | OIJ | Class 2 | Radiology | No | 2020-08-21 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2021-08-04 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2021-08-04 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2021-08-04 |
Proprietary Names
Biopsy Needle Guide Kit; Disposable Needle Guides; Reusable Needle Guides
Labat series Diagnostic Ultrasound System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device