FDA Registration
Active
🇨🇳 China
Hangzhou VivaLNK Medical Technology Co.,LTD.
Reg #: 3019737388
·
FEI: 3019737388
·
Expires 2026
Products
4
Proprietary Names
17
Establishment Types
1
Classifications
4
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Registration Details
- Registration Name
- Hangzhou VivaLNK Medical Technology Co.,LTD.
- Registration Number
- 3019737388
- FEI Number
- 3019737388
- Status
- Active
- Expiry Year
- 2026
- 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
- K191088
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 |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-01-04 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2020-01-23 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2017-02-02 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2018-07-23 |
Proprietary Names
Checkme O2/SpO2oxiband sleepmonitor
VV330 Continuous ECG Platform
VV330 Continuous ECG Recorder
VV350 Continuous ECG Platform
VV350 Continuous ECG Recorder
VV360 Continuous ECG Recorder
VV360 Continuous ECG Platform
Fever Scout Continuos monitoring thermometer
Continuos monitoring thermometer
Continuos monitoring thermometer - VV200
Temperature Adhesive
Disposable Hydrogel Adhesive
Fever Scout Adhesive
Hydrogel Adhesive
VivaLNK Adhesive Patch
Infrared Thermometer
Oxyfit
Establishment Types
Export Device to the United States But Perform No Other Operation on Device