FDA Registration
Active
🇨🇳 China
AcuSee AS-P1000 System
Reg #: 3018884581
·
FEI: 3018884581
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- WEIPENG (SUZHOU) MEDICAL DEVICES CO., LTD.
- Registration Number
- 3018884581
- FEI Number
- 3018884581
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 218 Xinghu St., Unit 207, Building B2, BIOBAY
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K202119
Owner / Operator
- Firm Name
- Weipeng (Suzhou) Medical Devices Co., Ltd.
- Operator Number
- 10083897
- Address
- 218 Xinghu St., Unit 207, Building B2, BIOBAY
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215123
- Country
- CN
- Correspondent
- Bin Yang
US Agent
- Business Name
- Vibronix Inc.
- Contact Name
- Rui Li
- Address
- 1281 WIn Hentschel Blvd
- City
- West Lafayette
- State
- IN
- ZIP
- 47906
- Country
- US
- [email protected]
- Phone
- 765 4268578
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2021-12-28 |
Proprietary Names
AcuSee AS-P1000 System
Establishment Types
Manufacture Medical Device