FDA Registration
Active
🇨🇳 China
Zoomax Luna 6
Reg #: 3014656175
·
FEI: 3014656175
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
10
Classifications
1
Registration Details
- Registration Name
- ZOOMAX TECHNOLOGY CO., LIMITED
- Registration Number
- 3014656175
- FEI Number
- 3014656175
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9F, Building D, Paradise Software Park, No.3 Xidoumen Road
- City
- Hangzhou Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- ZOOMAX TECHNOLOGY CO., LIMITED
- Operator Number
- 10058836
- Address
- 9F, Building D, Paradise Software Park, No.3 Xidoumen Road
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 310012
- Country
- CN
- Correspondent
- Stella Shen
US Agent
- Business Name
- ZOOMAX (USA) INC.
- Contact Name
- Rebecca Chen
- Address
- 6 Liberty Square #2572
- City
- Boston
- State
- MA
- ZIP
- 02109
- Country
- US
- [email protected]
- Phone
- 508 2866866
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Reading, Television, Closed-Circuit | HJG | Class 1 | Ophthalmic | No | 2018-11-29 |
Proprietary Names
Zoomax Luna 6
Zoomax Snow 12
Zoomax Snow Pad
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)
Develop Specifications But Do Not Manufacture At This Facility
Remanufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Foreign Private Label Distributor
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Reprocess Single-Use Device