FDA Registration
Active
🇹🇼 Taiwan
AURORA OPTIC INC.
Reg #: 3013202270
·
FEI: 3013202270
·
Expires 2026
Products
7
Proprietary Names
8
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- AURORA OPTIC INC.
- Registration Number
- 3013202270
- FEI Number
- 3013202270
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- no. 6 INDUSTRIAL FIFTH ROAD, TOU CHIAU, INDUSTRIAL PARK
- City
- CHIAYI
- Country
- TW
Owner / Operator
- Firm Name
- AURORA OPTIC INC.
- Operator Number
- 10052355
- Address
- no. 6 INDUSTRIAL FIFTH ROAD, TOU CHIAU, INDUSTRIAL PARK
- City
- CHIAYI
- State
- TW-CYQ
- Postal Code
- 62155
- Country
- TW
- Correspondent
- Nevies LEE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Magnifier, Hand-Held, Low-Vision | HJF | Class 1 | Ophthalmic | No | 2016-07-20 |
| Lens, Spectacle (Prescription), For Reading Discomfort | NJH | Class 1 | Ophthalmic | No | 2019-12-19 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2016-07-20 |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | Class 1 | Ophthalmic | No | 2016-07-20 |
| Frame, Spectacle | HQZ | Class 1 | Ophthalmic | No | 2016-07-20 |
| Spectacle, Magnifying | HOI | Class 1 | Ophthalmic | No | 2016-07-20 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2016-07-20 |
Proprietary Names
Magnifier, Hand-Held, Low-Vision
Lens, spectacle (prescription), for reading discomfort
Spectacle, Magnifying
SHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR)
sunglasses
Lens, Spectacle, Non-custom(Prescription)
Frame, Spectacle
Sunglasses
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device