FDA Registration
Active
🇨🇳 China
SHENZHEN VIATOM TECHNOLOGY CO., LTD.
Reg #: 3011200896
·
FEI: 3011200896
·
Expires 2026
Products
9
Proprietary Names
33
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- SHENZHEN VIATOM TECHNOLOGY CO., LTD.
- Registration Number
- 3011200896
- FEI Number
- 3011200896
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Floor 3, Building 9, Baiwangxin Industrial Park, No.1002 Songbai Road, Yangguang Community, Xili Street, Nanshan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K190207
Owner / Operator
- Firm Name
- Shenzhen Viatom Technology Co., Ltd.
- Operator Number
- 10050841
- Address
- 901, Building West, Lepu Tower, No.66 Xingke Road, Xili Community, Xili Street, Nanshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518055
- Country
- CN
- Correspondent
- Zhou Saixin
US Agent
- Business Name
- Hlongmed International Ltd.
- Contact Name
- Anny zhao
- Address
- 1312 17th Street#692 Denver,CO 80202
- City
- Denver
- State
- CO
- ZIP
- 80202
- Country
- US
- [email protected]
- Phone
- 503 3344880
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-08-19 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-12-06 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2016-01-11 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2023-06-28 |
| Oximeter, Wellness | PGJ | Class 2 | Cardiovascular | No | 2018-11-11 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2022-12-06 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2022-12-06 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2022-12-06 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2020-07-06 |
Proprietary Names
Wireless Blood Pressure Monitor
AirBP Blood Pressure Monitor
Oxyfit
Checkme Pro Health Monitor
Checkme lite
WEARO2
S13B
SA-10BW
S13
S6W
S11
O2RING
S8-AW
SleepU
S4
S12
S10
S9
Oxylink
Oxiband-1
S14
S3
KidsO2
Babytone Sleep Sock (S1)
Babytone Sleep Sock + (S1)
Baby Sleep Monitor S1
Baby Sleep Monitor BabyO2 S2
Babytone Sleep Satview (S1)
Baby Sleep Monitor BabyO2
Pulse Oximeter, Oxiband, Checkme O2
Wireless Probe Type Ultrasound Scanner
Pulse Oximeter PO2, PO2A, PO2B
Blood Pressure Monitor, models BP2, BP2A
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device