FDA Registration
Active
🇨🇳 China
iHealth Ease Wireless Blood Pressure Monitor, White(BP3L)
Reg #: 3003741676
·
FEI: 3003741676
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ANDON HEALTH CO., LTD
- Registration Number
- 3003741676
- FEI Number
- 3003741676
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 3 Jin Ping Street,Ya An Road,, NANKAI DISTRICT
- City
- TIANJIN
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K152003
Owner / Operator
- Firm Name
- ANDON HEALTH CO.,LTD
- Operator Number
- 9055208
- Address
- No. 3 Jin Ping Street,Ya An Road,, NANKAI DISTRICT
- City
- TIANJIN
- State
- CN-NOTA
- Postal Code
- 300190
- Country
- CN
- Correspondent
- YI - LIU
US Agent
- Business Name
- IHEALTH LABS, INC
- Contact Name
- Yange Wang
- Address
- 880 W MAUDE AVE,SUNNYVALE , CALIFORNIA , 94085 , UNITED STATES
- City
- Sunnyvale
- State
- CA
- ZIP
- 94085
- Country
- US
- [email protected]
- Phone
- 408 6638349
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2015-09-24 |
Proprietary Names
iHealth Ease Wireless Blood Pressure Monitor, White(BP3L)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device