Shenzhen Viatom Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 9 device types, 18 products catalogued, 5 clearances.
Shenzhen Viatom Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Electrocardiograph and 7 other device types. 18 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
Registration
| Registered name | SHENZHEN VIATOM TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011200896 |
| FEI number | 3011200896 |
| DUNS | 421357243 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳源动创新科技有限公司 |
|---|---|
| Unified social credit code | 91440300064951198G |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Floor 3, Building 9, Baiwangxin Industrial Park, No.1002 Songbai Road |
| Postal code | 518055 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrocardiograph | Class 2 | Blood Pressure Monitor, models BP2, BP2A | 2020 | 18 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class 2 | Checkme Pro Health Monitor, Checkme lite | 2016 | 17 |
| Oximeter | Class 2 | Oxyfit, Pulse Oximeter, Oxiband, Checkme O2, Pulse Oximeter PO2, PO2A, PO2B | 2019 | 70 |
| Oximeter, Infrared, Sporting, Aviation | Class 2 | S6W, S8-AW, S4, Oxiband-1, S14, S9 and 12 more | 2023 | 29 |
| Oximeter, Wellness | Class 2 | Babytone Sleep Sock (S1), Baby Sleep Monitor S1, Baby Sleep Monitor BabyO2, Babytone Sleep Satview (S1), Baby Sleep Monitor BabyO2 S2 | 2018 | 19 |
| System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | Wireless Probe Type Ultrasound Scanner | 2022 | 22 |
| System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | Wireless Probe Type Ultrasound Scanner | 2022 | 37 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Blood Pressure Monitor, models BP2, BP2A, Wireless Blood Pressure Monitor, AirBP Blood Pressure Monitor | 2019 | 98 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | Wireless Probe Type Ultrasound Scanner | 2022 | 44 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Pulse Oximeter | OCH | 12 |
| Viatom | DQA | 4 |
| Pulse Oximeter | DQA | 3 |
| Lepu Medical | DXN | 2 |
| Wellue | DXN | 2 |
| BP2A Blood Pressure Monitor | DXN | 1 |
| Wellue/Viatom | DPS | 1 |
| BodiMetrics | MWI | 1 |
| Viatom Pulse Oximeter | DQA | 1 |
| Checkme | DPS | 1 |
| Lepu Medical | DQA | 1 |
| Pulse Oximeter | PGJ | 1 |
| Sleepimage | DQA | 1 |
| BP2 Blood Pressure Monitor | DPS | 1 |
| Wellue/Viatom | DXN | 1 |
| Viatom | MWI | 1 |
| Checkme | DXN | 1 |
| Wellue Checkme O2 Max | DQA | 1 |
Clearances
5 clearances name Shenzhen Viatom Technology Co., Ltd. as applicant. 2 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 |
|---|---|---|---|---|
| K242876 | 2025-02-28 | DQA | Traditional | This company |
| K203812 | 2022-11-08 | DQA | Traditional | This company |
| K193348 | 2020-06-25 | DXN | Traditional | This company |
| K191088 | 2019-12-02 | DQA | Traditional | This company |
| K190207 | 2019-08-19 | DXN | Traditional | This company |
| K211321 | 2022-10-13 | IYN | Abbreviated | Guangzhou Sonostar Technologies Co., Ltd. |
| K150869 | 2015-12-10 | MWI | Traditional | Viatom Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Main products | Pulse oximeters, ECG monitors, Blood pressure monitors, Wearable ECG recorder, Vital signs monitors |
| Certifications | FDA, CE, JPAL |
| Export markets | 200+ countries and regions |
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.