FDA Registration
Active
🇨🇳 China
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
Reg #: 3003981912
·
FEI: 3003981912
·
Expires 2026
Products
4
Proprietary Names
8
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
- Registration Number
- 3003981912
- FEI Number
- 3003981912
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Bldg,2,Baimiao Ind.Park,, Economic Development Zone,Wuchang
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K160999
Owner / Operator
- Firm Name
- HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
- Operator Number
- 9054972
- Address
- Bldg,2,Baimiao Ind.Park,, Economic Development Zone,Wuchang
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 310023
- Country
- CN
- Correspondent
- Ahneo - Yang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2016-08-01 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-07-09 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2022-09-28 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2010-01-27 |
Proprietary Names
FT-100E
FT-100D
FT-100A
FT-100B
Infrared ear thermometer( ET-100A/ET-100B/ ET-100D/ ET-100E/ ET-100G/ ET-100I/ ET-100J)
Infrared forehead thermometer(FT-100A/FT-100B/FT-100D/FT-100E/FT-100I/ET-100EF)
Digital thermometer( DTseries including DT-12A/DT-K111I/DT-K111J)
JASUN
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device