FDA Registration
Active
🇨🇳 China
Electric Breast Pump XB-8116, XB-8122-1, XB-8122-2, XB-8128
Reg #: 3010334650
·
FEI: 3010334650
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Jiangsu Xinbei Electrical Appliances CO., LTD.
- Registration Number
- 3010334650
- FEI Number
- 3010334650
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO. 115 Xinjin Road,, Xinwu District
- City
- Wuxi Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K151284
Owner / Operator
- Firm Name
- Jiangsu Xinbei Electrical Appliances Co., Ltd
- Operator Number
- 10048891
- Address
- NO. 115 Xinjin Road,, Xinwu District
- City
- Wuxi
- State
- Jiangsu
- Postal Code
- 214000
- Country
- CN
- Correspondent
- Shaozhong Chen
US Agent
- Business Name
- Mid-link International Inc
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive, Suite 301
- City
- Bellingham
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2016-07-10 |
Proprietary Names
Electric Breast Pump XB-8116, XB-8122-1, XB-8122-2, XB-8128
Electric Breast Pump, XB-8782, XB-8769, XB-8771, XB-8760, XB-8780, XB-8768, XB-8762, XB-8725, XB-8731, XB-8615
Electric Breast Pump XB-8100, XB-8102
XB-8782, XB-8780-2, XB-8760 Electric Breast Pump
Lucina Baby Breast Pump AM6113, AM6111, AM8133
Breast Pump XB-8138
NCVI Electric Breast Pump AM8100, AM8102, AM8128, AM8129, AM8116-US, AM8122-1, AM8122-2, AM8122-3, AM8138, AM8786
Electric Breast Pump XB-8129
Breast Pump AM-8787, XB-8787
Establishment Types
Manufacture Medical Device