FDA Registration
Active
🇨🇳 China
Electric breast pump with models MY-371,MY-372,MY-373,MY-374,MY-375,MY-376,MY-378,MY-379,MY-380, V3
Reg #: 3009617411
·
FEI: 3009617411
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
- Registration Number
- 3009617411
- FEI Number
- 3009617411
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 101, Building 1, No.15 Xiusheng 2nd Road, Xiuxin Community, Kengzi Street, Pingshan District,
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K231595
Owner / Operator
- Firm Name
- Shenzhen Changkun Technology Co., Ltd.
- Operator Number
- 10071297
- Address
- 101, Building 1, No.15 Xiusheng 2nd Road, Xiuxin Community, Kengzi Street, Pingshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518118
- Country
- CN
- Correspondent
- Qingpeng Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2023-11-13 |
Proprietary Names
Electric breast pump with models MY-371,MY-372,MY-373,MY-374,MY-375,MY-376,MY-378,MY-379,MY-380, V3
Electric breast pump with models MY-381,MY-382,MY-383,MY-384,MY-385,MY-386
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device