Hangzhou VivaLNK Medical Technology Co., Ltd.
Registered establishment in Hangzhou, Zhejiang, China. 4 device types.
Hangzhou VivaLNK Medical Technology Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Oximeter, Tape And Bandage, Adhesive and 2 other device types. Its earliest product listing with the FDA dates from 2017.
Registration
| Registered name | Hangzhou VivaLNK Medical Technology Co.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3019737388 |
| FEI number | 3019737388 |
| Establishment type | Exporter |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | Room 502, Floor 5, Building 2, No.2, 8th Avenue, Baiyang Sub-district, Qiantang District, |
| Postal code | 310000 |
| Country | China |
Group
Hangzhou VivaLNK Medical Technology Co., Ltd. is one of 3 plants registered under VivaLnk Inc.
| Plant | City | Device types |
|---|---|---|
| Dongguan CFE Electronic Co., Ltd. | Dongguan | 2 |
| Shenzhen Omori Biological Technology Co., Ltd. | Shenzhen | 1 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Continuous Measurement Thermometer | Class 2 | Infrared Thermometer, Continuos monitoring thermometer, Fever Scout Continuos monitoring thermometer, Continuos monitoring thermometer – VV200 | 2017 | 115 |
| Oximeter | Class 2 | Oxyfit, Checkme O2/SpO2oxiband sleepmonitor | 2022 | 70 |
| Tape And Bandage, Adhesive | Class 1 | Hydrogel Adhesive, Temperature Adhesive, VivaLNK Adhesive Patch, Fever Scout Adhesive, Disposable Hydrogel Adhesive | 2018 | 353 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | Class 2 | VV360 Continuous ECG Recorder, VV330 Continuous ECG Platform, VV330 Continuous ECG Recorder, VV350 Continuous ECG Recorder, VV350 Continuous ECG Platform, VV360 Continuous ECG Platform | 2020 | 11 |
Clearances
No clearance names Hangzhou VivaLNK Medical Technology Co., Ltd. as applicant. 5 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K221039 | 2022-12-20 | FLL | Traditional | Shenzhen AOJ Medical Technology Co., Ltd. |
| K203812 | 2022-11-08 | DQA | Traditional | Shenzhen Viatom Technology Co., Ltd. |
| K191870 | 2020-01-07 | DRG | Traditional | Vivalnk, Inc. |
| K191088 | 2019-12-02 | DQA | Traditional | Shenzhen Viatom Technology Co., Ltd. |
| K162137 | 2017-01-19 | FLL | Traditional | Vivalnk, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Employees | 49 |
| Main products | temperature monitoring patch, ECG monitoring patch, medical sensor SDK, telemedicine cloud platform, remote patient monitoring systems |
| Certifications | FDA-cleared, GxP-compliant, Internet Pharmaceutical Information Service License |
| Export markets | 51 countries |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.