FDA Registration
Active
🇨🇳 China
PULSE OXIMETER (model: PO6)
Reg #: 3003741676
·
FEI: 3003741676
·
Expires 2025
Products
1
Proprietary Names
3
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
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 |
|---|---|---|---|---|---|
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2022-07-06 |
Proprietary Names
PULSE OXIMETER (model: PO6)
iHealth (model: PO3)
PULSE OXIMETER (model: PO6L)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device