FDA Registration
Active
🇨🇳 China
WUXI ZONTAI INT'L CORPORATION LTD.
Reg #: 3009275598
·
FEI: 3009275598
·
Expires 2026
Products
22
Proprietary Names
23
Establishment Types
3
Classifications
22
Registration Details
- Registration Name
- WUXI ZONTAI INT'L CORPORATION LTD.
- Registration Number
- 3009275598
- FEI Number
- 3009275598
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO. 455 GUANGRUI RD
- City
- WUXI Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- WUXI ZONTAI INT'L CORPORATION LTD.
- Operator Number
- 10049823
- Address
- NO. 455 GUANGRUI RD
- City
- WUXI
- State
- Jiangsu
- Postal Code
- 214011
- Country
- CN
- Correspondent
- Fang Li
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Lens, Trial, Ophthalmic | HPC | Class 1 | Ophthalmic | No | 2015-08-05 |
| Fixation, Vision Training, Binocular | NXR | Class 1 | Ophthalmic | No | 2026-01-24 |
| Prism, Bar, Ophthalmic | HKW | Class 1 | Ophthalmic | No | 2016-10-21 |
| Frame, Trial, Ophthalmic | HPA | Class 1 | Ophthalmic | No | 2015-08-05 |
| Prism, Rotary, Ophthalmic | HKQ | Class 1 | Ophthalmic | No | 2026-01-24 |
| Spectacle Microscope, Low-Vision | HKC | Class 1 | Ophthalmic | No | 2016-10-22 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2015-08-05 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2017-11-10 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2016-10-21 |
| Frame, Spectacle | HQZ | Class 1 | Ophthalmic | No | 2015-08-05 |
| Table, Instrument, Powered, Ophthalmic | HRJ | Class 1 | Ophthalmic | No | 2015-08-05 |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | Class 1 | Ophthalmic | No | 2015-08-05 |
| Ruler, Nearpoint (Punctometer) | HLE | Class 1 | Ophthalmic | No | 2026-01-24 |
| Chair, Ophthalmic, Ac-Powered | HME | Class 1 | Ophthalmic | No | 2016-10-21 |
| Loupe, Binocular, Low Power | HJH | Class 1 | Ophthalmic | No | 2016-10-21 |
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 2015-08-05 |
| Exophthalmometer | HLS | Class 1 | Ophthalmic | No | 2017-11-10 |
| Retinoscope, Battery-Powered | HKM | Class 1 | Ophthalmic | No | 2016-10-21 |
| Rack, Skiascopic | HMH | Class 1 | Ophthalmic | No | 2015-08-05 |
| Ophthalmoscope, Battery-Powered | HLJ | Class 2 | Ophthalmic | No | 2016-10-21 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2015-08-05 |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 2015-08-05 |
Proprietary Names
TRIAL LENS SET
Wolff Wands, Fixation Stick, Fixation Cube, Brock String
Ophthalmic prism bar
TRIAL FRAME
Maddox Phoria Measure
Low-vision magnifier
OCCLUDER
Sunglasses
Vision chart
EYE GLASS FRAME
OPHTHALMIC POWERED TABLE
CONFIRMATION FLIPPER
SPECTACLE LENS
Accommodative Convergence Ruler
Ophthalmic chair
Binocular loupe
LENSMETER
Exophthalmometer
Retinoscope
SKIASCOPIC RACK
Ophthalmoscope
REFRACTOMETER
PHOROTER
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device