FDA Registration
Active
🇨🇳 China
ZUMAX MEDICAL CO, LTD.
Reg #: 3006252153
·
FEI: 3006252153
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ZUMAX MEDICAL CO, LTD.
- Registration Number
- 3006252153
- FEI Number
- 3006252153
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5 ZHIYING STREET, SUZHOU NEW DISTRICT
- City
- SUZHOU,JIANGSU
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K131939
Owner / Operator
- Firm Name
- ZUMAX MEDICAL CO, LTD.
- Operator Number
- 9093892
- Address
- 5 ZHIYING STREET, SUZHOU NEW DISTRICT
- City
- SUZHOU
- State
- Jiangsu
- Postal Code
- 215129
- Country
- CN
- Correspondent
- XIANGDONG - LI
US Agent
- Business Name
- Image Systems, Inc
- Contact Name
- Simon Wang
- Address
- 136 Clarken Drive
- City
- West Orange
- State
- NJ
- ZIP
- 07052
- Country
- US
- [email protected]
- Phone
- 973 7318515
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ophthalmoscope, Ac-Powered | HLI | Class 2 | Ophthalmic | No | 2016-09-12 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)