FDA Registration
Active
🇨🇳 China
hCG Urine Test Cassette
Reg #: 3013077867
·
FEI: 3013077867
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SAFECARE BIOTECH(HANGZHOU)CO.,LTD
- Registration Number
- 3013077867
- FEI Number
- 3013077867
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 2/203, No. 18 Haishu Road, Cangqian Sub-district,Yuhang District
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K200133
Owner / Operator
- Firm Name
- Safecare Biotech(Hangzhou)Co.,Ltd
- Operator Number
- 10052102
- Address
- Building 2/203 No.18 Haishu Rd.,, Cangqian Sub-district,Yuhang District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311121
- Country
- CN
- Correspondent
- Alex Qiu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2020-09-15 |
Proprietary Names
hCG Urine Test Cassette
hCG Urine Test Strip
hCG Urine Test Midstream
Establishment Types
Manufacture Medical Device