FDA Registration
Active
🇨🇳 China
ZOOMAX TECHNOLOGY CO., LIMITED
Reg #: 3014656175
·
FEI: 3014656175
·
Expires 2026
Products
5
Proprietary Names
11
Establishment Types
10
Classifications
5
Registration Details
- Registration Name
- ZOOMAX TECHNOLOGY CO., LIMITED
- Registration Number
- 3014656175
- FEI Number
- 3014656175
- Status
- Active
- Expiry Year
- 2026
- 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
- 339 8008033
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Reading, Television, Closed-Circuit | HJG | Class 1 | Ophthalmic | No | 2018-11-29 |
| Spectacle, Magnifying | HOI | Class 1 | Ophthalmic | No | 2018-11-01 |
| Audiometer | EWO | Class 2 | Ear, Nose, Throat | No | 2025-04-23 |
| Aid, Vision, Electronic, Battery-Powered | HPG | Class 1 | Ophthalmic | No | 2018-12-10 |
| Magnifier, Hand-Held, Low-Vision | HJF | Class 1 | Ophthalmic | No | 2018-11-01 |
Proprietary Names
Zoomax Luna 6
Zoomax Snow Pad
Zoomax Snow 12
Zoomax Luna EYE
Zoomax Snow Eye
Zoomax Luna HD 24 Pro
Insert Earphones
Zoomax Luna 8
Zoomax Luna S
Zoomax Luna Eye
Zoomax Acesight VR
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Sterilize Medical Device for Another Party (Contract Sterilizer)
Reprocess Single-Use Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Remanufacture Medical Device
Foreign Private Label Distributor
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device