FDA Registration
Active
🇨🇳 China
Arm Blood Pressure Monitor, models of AES-U231, AES-U371, AES-U372, AES-U373, AES-U381, AES-U382
Reg #: 3009889471
·
FEI: 3009889471
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ALICN MEDICAL SHENZHEN, INC
- Registration Number
- 3009889471
- FEI Number
- 3009889471
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 4C, Building 1, Zhongcheng Biomedical Industrial Park, No. 21 Linhui Road, Jinsha Community, Kengzi Street, Pingshan District,
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K231050
Owner / Operator
- Firm Name
- Alicn Medical Shenzhen, Inc
- Operator Number
- 10045880
- Address
- Room 4C, Building 1, Zhongcheng Biomedical Industrial Park, No. 21 Linhui Road, Jinsha Community,Kengzi Street, Pingshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518118
- Country
- CN
- Correspondent
- Renxiong Huang
US Agent
- Business Name
- HY AMERICA INC
- Contact Name
- angela Li
- Address
- 4402 Gertrude Dr
- City
- Fremont
- State
- CA
- ZIP
- 94536
- Country
- US
- [email protected]
- Phone
- 510 5567677
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-10-16 |
Proprietary Names
Arm Blood Pressure Monitor, models of AES-U231, AES-U371, AES-U372, AES-U373, AES-U381, AES-U382
Arm Blood Pressure Monitor, models of AES-U391, AES-U392, AES-U393, AES-U301, AES-U302
Establishment Types
Manufacture Medical Device