FDA Registration
Active
🇨🇳 China
GINO OPTICAL (SHANGHAI) CO., LTD.
Reg #: 3009515444
·
FEI: 3009515444
·
Expires 2026
Products
15
Proprietary Names
19
Establishment Types
2
Classifications
15
Registration Details
- Registration Name
- GINO OPTICAL (SHANGHAI) CO., LTD.
- Registration Number
- 3009515444
- FEI Number
- 3009515444
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.800, Qingdai RD, Pudong
- City
- Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- GINO OPTICAL (SHANGHAI) CO., LTD.
- Operator Number
- 10083895
- Address
- No.800, Qingdai RD, Pudong
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201318
- Country
- CN
- Correspondent
- Jianfang Ye
US Agent
- Business Name
- SOUTH BAY INNOVATION LLC
- Contact Name
- Yueting Zhu
- Address
- 23545 Crenshaw Blvd Ste 106
- City
- Torrance
- State
- CA
- ZIP
- 90505
- Country
- US
- [email protected]
- Phone
- 424 3769142
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Projector, Ophthalmic | HOS | Class 1 | Ophthalmic | No | 2022-03-10 |
| Lens, Spectacle (Prescription), For Reading Discomfort | NJH | Class 1 | Ophthalmic | No | 2021-12-28 |
| Pupillometer, Manual | HLH | Class 1 | Ophthalmic | No | 2022-03-10 |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 2022-03-10 |
| Frame, Spectacle | HQZ | Class 1 | Ophthalmic | No | 2021-12-28 |
| Table, Instrument, Powered, Ophthalmic | HRJ | Class 1 | Ophthalmic | No | 2022-03-10 |
| Tester, Color Vision | HIT | Class 1 | Ophthalmic | No | 2022-03-10 |
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 2022-03-10 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2022-03-10 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2022-03-10 |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | Class 1 | Ophthalmic | No | 2021-12-28 |
| Frame, Trial, Ophthalmic | HPA | Class 1 | Ophthalmic | No | 2022-03-10 |
| Device, Measuring, Lens Radius, Ophthalmic | HLF | Class 1 | Ophthalmic | No | 2022-03-10 |
| Set, Lens, Trial, Ophthalmic | HPC | Class 1 | Ophthalmic | No | 2021-12-28 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2021-12-28 |
Proprietary Names
Projector, ophthalmic
Lens
PD METER
Refractor, manual, non- powered, including phoropter
Frame
Table, instrument, powered, ophthalmic
Tester, color vision
LENS METER
Instrument, measuring, lens, ac-powered
Refractometer, ophthalmic
Chart, visual acuity
Reading Glasses
TRIAL FRAME
Frame, trial, ophthalmic
FRAME HEATER
TRIAL LENS SET
Set, lens, trial, ophthalmic
Trial Lens
Sunglasses
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device