FDA Registration
Active
🇨🇳 China
VIVACHEK BIOTECH (HANGZHOU) CO., LTD
Reg #: 3013223546
·
FEI: 3013223546
·
Expires 2025
Products
2
Proprietary Names
0
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- VIVACHEK BIOTECH (HANGZHOU) CO., LTD
- Registration Number
- 3013223546
- FEI Number
- 3013223546
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.17 Wuzhou Road, Donghu Street, Linping District, Hangzhou, 311100, Building 2 and Building 3, No.17 Jianxing Road, Taozhu Street, Zhuji, 311800
- City
- Hangzhou, Zhuji Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K220475
Owner / Operator
- Firm Name
- VivaChek Biotech (Hangzhou) Co., Ltd
- Operator Number
- 10055002
- Address
- No.17 Wuzhou Road, Donghu Street, Linping District,
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311100
- Country
- CN
- Correspondent
- Frank Shui
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2022-11-17 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2022-11-17 |
Establishment Types
Repack or Relabel Medical Device