FDA Registration
Active
🇨🇳 China
Medke Spo2 sensor, P8119, P9119, P8325A, P8310F
Reg #: 3012804266
·
FEI: 3012804266
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN MEDKE TECHNOLOGY CO., LTD.
- Registration Number
- 3012804266
- FEI Number
- 3012804266
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 401, 503, Bldg. A1, Anle Ind. Zone, No.172, Hangcheng RD, Sanwei Community, Hangcheng Street, Baoan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K152390
Owner / Operator
- Firm Name
- Shenzhen Medke Technology Co., Ltd.
- Operator Number
- 10053289
- Address
- 401, 503, Bldg. A1, Anle Ind. Zone, No.172, Hangcheng RD, Sanwei Community, Hangcheng Street, Baoan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518126
- Country
- CN
- Correspondent
- Tate Zhuo
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 |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2016-11-16 |
Proprietary Names
Medke Spo2 sensor, P8119, P9119, P8325A, P8310F
Medke SpO2 Sensor, P9115S, P9318E, P9318H, P9325A, P9310F, P9119A, P8119A, P8115F, P8325A, P8310F
Establishment Types
Manufacture Medical Device