FDA Registration
Active
🇨🇳 China
iHealth COVID-19/Flu A&B Rapid Test ( Model no. ICF-3000)
Reg #: 3016850770
·
FEI: 3016850770
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOHIT HEALTHCARE (HEFEI) CO., LTD.
- Registration Number
- 3016850770
- FEI Number
- 3016850770
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Biouhan Bio-Industrial Park, Northeast Corner, Intersection of Kongquetai Road and Chang'an Road, High-tech Zone
- City
- Hefei Anhui
- Country
- CN
Owner / Operator
- Firm Name
- Biohit Healthcare (Hefei) Co., Ltd.
- Operator Number
- 10069805
- Address
- Biouhan Bio-Industrial Park, Northeast Corner, Intersection of Kongquetai Road and Chang'an Road, High-tech Zone
- City
- Hefei
- State
- Anhui
- Postal Code
- 230000
- Country
- CN
- Correspondent
- Linda Wang
US Agent
- Business Name
- Willow Glen Consultancy LLC
- Contact Name
- Wen Wang
- Address
- 8880 Rio San Diego Drive, #800
- City
- San Diego
- State
- CA
- ZIP
- 92108
- Country
- US
- [email protected]
- Phone
- 619 8690249
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Covid-19 Multi-Analyte Antigen Device | QMN | Class N | Unknown | No | 2024-05-10 |
Proprietary Names
iHealth COVID-19/Flu A&B Rapid Test ( Model no. ICF-3000)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)