FDA Registration
Active
🇨🇳 China
Alcohol Tester, Breathalyzer
Reg #: 3007037208
·
FEI: 3007037208
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Hanwei Electronics Group Corporation
- Registration Number
- 3007037208
- FEI Number
- 3007037208
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.169, Xuesong Road, National Hi-Tech Zone
- City
- Zhengzhou Henan
- Country
- CN
Owner / Operator
- Firm Name
- Hanwei Electronics Group
- Operator Number
- 10033905
- Address
- No. 169 Xuesong Road, National Hi-Tech Zone
- City
- Zhengzhou
- State
- Henan
- Postal Code
- 450001
- Country
- CN
- Correspondent
- Bob Sun
US Agent
- Business Name
- KHN Solutions LLC
- Contact Name
- Keith Nothacker
- Address
- 300 Broadway Ste 26
- City
- San Francisco
- State
- CA
- ZIP
- 94133
- Country
- US
- [email protected]
- Phone
- 415 6939756
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | DJZ | Class 1 | Clinical Toxicology | No | 2018-08-21 |
Proprietary Names
Alcohol Tester, Breathalyzer
Breathalyzer AT800
Breathalyzer AT808
Breathalyzer AT188
Breathalyzer AT202
Breathalyzer AT218
Breathalyzer AT7000
Breathalyzer AT602
Breathalyzer AT8030
Breathalyzer AT8060
Breathalyzer AT818
Breathalyzer AT7300
Breathalyzer AT198
Breathalyzer AT8020
Establishment Types
Remanufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device