FDA Registration
Active
🇨🇳 China
Blood Pressure Monitor (RAK282, RAK283, RAK286, RAK288, RAK289)
Reg #: 3016707048
·
FEI: 3016707048
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN RUIANKANG TECHNOLOGY CO., LTD.
- Registration Number
- 3016707048
- FEI Number
- 3016707048
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Floor 1 and 2, No. 8, Zhugushi Chunyang Industrial Park, Wulian Community, Longgang Street, Longgang District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K242528
Owner / Operator
- Firm Name
- Shenzhen Ruiankang Technology Co., Ltd.
- Operator Number
- 10090962
- Address
- Floor 1 and 2, No. 8, Zhugushi Chunyang Industrial Park, Wulian Community, Longgang Street, Longgang District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518100
- Country
- CN
- Correspondent
- Jinzhi Song
US Agent
- Business Name
- RGLM Consulting LLC
- Contact Name
- Roy Zhang
- Address
- 6113 Swift Current Way
- City
- Clarksville
- State
- MD
- ZIP
- 21029
- Country
- US
- [email protected]
- Phone
- 425 2364274
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2025-02-28 |
Proprietary Names
Blood Pressure Monitor (RAK282, RAK283, RAK286, RAK288, RAK289)
Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269)
Blood Pressure Monitor (RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)
Establishment Types
Manufacture Medical Device