FDA Registration
Active
🇨🇳 China
Breast pump/ breast pump spare parts /Zomee Double Breast Pump ZM-2/Zomee ZM-1
Reg #: 3017305129
·
FEI: 3017305129
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHANGHAI MAXCARE TECHNOLOGY CO.,LIMITED
- Registration Number
- 3017305129
- FEI Number
- 3017305129
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- BUILDING 2, NO.775 SIPING ROAD, HONGKOU DISTRICT
- City
- SHANGHAI
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K142479
Owner / Operator
- Firm Name
- SHANGHAI MAXCARE TECHNOLOGY CO.,LIMITED
- Operator Number
- 10072613
- Address
- BUILDING 2, NO.775 SIPING ROAD, HONGKOU DISTRICT
- City
- SHANGHAI
- State
- CN-SH
- Postal Code
- 200080
- Country
- CN
- Correspondent
- Wendy Zhang
US Agent
- Business Name
- SPICA MEDTECH CORP
- Contact Name
- Creekon Yang
- Address
- 1020 LINCOLN ST
- City
- Denver
- State
- CO
- ZIP
- 80203
- Country
- US
- [email protected]
- Phone
- 720 6176666
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2023-07-24 |
Proprietary Names
Breast pump/ breast pump spare parts /Zomee Double Breast Pump ZM-2/Zomee ZM-1
Establishment Types
Export Device to the United States But Perform No Other Operation on Device