FDA Registration
Active
🇨🇳 China
One Step hCG Test Strip, One Step hCG Test Cassette, One Step hCG Test Midstream
Reg #: 3005951403
·
FEI: 3005951403
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AID UNITED INTERNATIONAL CO., LIMITED
- Registration Number
- 3005951403
- FEI Number
- 3005951403
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ROOM 505,T2, NO. 168, TAIHONG ROAD
- City
- SHANGHAI
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K183097
Owner / Operator
- Firm Name
- AID UNITED INTERNATIONAL CO., LIMITED
- Operator Number
- 9090586
- Address
- ROOM 520, NO. 1065, WUZHONG ROAD
- City
- SHANGHAI
- State
- CN-SH
- Postal Code
- 201103
- Country
- CN
- Correspondent
- HANSON - WANG
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2023-06-08 |
Proprietary Names
One Step hCG Test Strip, One Step hCG Test Cassette, One Step hCG Test Midstream
Establishment Types
Export Device to the United States But Perform No Other Operation on Device