FDA Registration
Active
🇨🇳 China
Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683
Reg #: 3017207990
·
FEI: 3017207990
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN YUEZHONGXING TECHNOLOGY CO.,LTD
- Registration Number
- 3017207990
- FEI Number
- 3017207990
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building E105,Haowei Industrial park,No.8Qinglan 1st Road,Zhukeng Community,Long Tian street,Pingshan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222926
Owner / Operator
- Firm Name
- Shenzhen Yuezhongxing Technology Co.,Ltd
- Operator Number
- 10082993
- Address
- Building E105,Haowei Industrial park,No.8Qinglan 1st Road,Zhukeng Community,Long Tian street,Pingshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518015
- Country
- CN
- Correspondent
- Yuchao Chen
US Agent
- Business Name
- WISELINK MEDICAL INC.
- Contact Name
- Nelson Xie
- Address
- 666 Old Country Rd Ste 201 Garden City Ny 11530
- City
- Garden City
- State
- NY
- ZIP
- 11530
- Country
- US
- [email protected]
- Phone
- 631 2558110
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-05-11 |
Proprietary Names
Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683
Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681
Arm Blood Pressure Monitor, Model Name:121, Arm Blood Pressure Monitor, Model Name: 121R
Establishment Types
Manufacture Medical Device