FDA Registration
Active
🇨🇳 China
Disposable Temperature Probe (model: ST5105A, ST6105A)
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
- K223807
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 |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-08-30 |
Proprietary Names
Disposable Temperature Probe (model: ST5105A, ST6105A)
Reusable Temperature Probe (model: ST1304, ST2304, ST3304, ST4304)
Establishment Types
Manufacture Medical Device