FDA Registration
Active
🇨🇳 China
Reusable NIBP Cuff: SC1311, SC1511, SC1611, SC1711, SC1811
Reg #: 3015616170
·
FEI: 3015616170
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN SINO-K MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3015616170
- FEI Number
- 3015616170
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4th Floor, Building 2, West Side of Xixiang Veterans Industry City, Gongle Community, Xixiang Street, Baoan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K231961
Owner / Operator
- Firm Name
- Shenzhen SINO-K Medical Technology Co., Ltd.
- Operator Number
- 10084033
- Address
- 4th Floor, Building 2, West Side of Xixiang Veterans Industry City, Gongle Community, Xixiang Street, Baoan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518101
- Country
- CN
US Agent
- Business Name
- Dynasty Medical Consulting Inc.
- Contact Name
- Linda Chen
- Address
- 302 Round Lake Dr
- City
- Rosenberg
- State
- TX
- ZIP
- 77469
- Country
- US
- [email protected]
- Phone
- 832 3809688
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2023-09-03 |
Proprietary Names
Reusable NIBP Cuff: SC1311, SC1511, SC1611, SC1711, SC1811
Disposable NIBP Cuff: SC0101, SC0102, SC0103, SC0104, SC0105, SC0106, SC0107, SC0108, SC0109, SC0110, SC0111, SC0112
Establishment Types
Manufacture Medical Device