FDA Registration
Active
🇨🇳 China
VV330 Continuous ECG Platform
Reg #: 3019737388
·
FEI: 3019737388
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Hangzhou VivaLNK Medical Technology Co.,LTD.
- Registration Number
- 3019737388
- FEI Number
- 3019737388
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 502, Floor 5, Building 2, No.2, 8th Avenue, Baiyang Sub-district, Qiantang District,
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K191870
Owner / Operator
- Firm Name
- VivaLnk Inc
- Operator Number
- 10049171
- Address
- 51 EAST CAMPBELL AVE., SUITE 160
- City
- Campbell
- State
- CA
- Postal Code
- 95008
- Country
- US
- Correspondent
- quoi v huynh
US Agent
- Business Name
- VIVALNK INC
- Contact Name
- quoi huynh
- Address
- 51 EAST CAMPBELL AVE., SUITE 160
- City
- Campbell
- State
- CA
- ZIP
- 95008
- Country
- US
- [email protected]
- Phone
- 408 8682898
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2020-01-23 |
Proprietary Names
VV330 Continuous ECG Platform
VV330 Continuous ECG Recorder
VV350 Continuous ECG Platform
VV350 Continuous ECG Recorder
Establishment Types
Export Device to the United States But Perform No Other Operation on Device