FDA Registration
Active
🇨🇳 China
Acon Biotech (Hangzhou) Co., Ltd.
Reg #: 3032171519
·
FEI: 3032171519
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Acon Biotech (Hangzhou) Co., Ltd.
- Registration Number
- 3032171519
- FEI Number
- 3032171519
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Qingshanhu Subdistrict, Linan District
- City
- Hangzhou Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- ACON Laboratories Inc.
- Operator Number
- 9033096
- Address
- 5850 Oberlin Drive, #340
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Catherine Shi
US Agent
- Business Name
- ACON LABORATORIES INC.
- Contact Name
- Catherine Shi
- Address
- 5850 Oberlin Drive, #340
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
- [email protected]
- Phone
- 858 8758068
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2021-10-22 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)