FDA Registration
Active
🇹🇼 Taiwan
IRENE Corporation
Reg #: 8043097
·
FEI: 3002855268
·
Expires 2026
Products
7
Proprietary Names
0
Establishment Types
2
Classifications
7
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Registration Details
- Registration Name
- IRENE Corporation
- Registration Number
- 8043097
- FEI Number
- 3002855268
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 283, Hsin-Nan Street, South District,
- City
- TAINAN
- Country
- TW
Owner / Operator
- Firm Name
- IRENE Corporation
- Operator Number
- 8043097
- Address
- No. 283, Hsin-Nan Street, South District,, --
- City
- TAINAN
- State
- TW-TNN
- Postal Code
- 702018
- Country
- TW
- Correspondent
- ALICE - KUO
US Agent
- Business Name
- Solar Bat Enterprises, Inc.
- Contact Name
- Gary Nesty
- Address
- 3628 E County Road 600 N
- City
- Brazil
- State
- IN
- ZIP
- 47834
- Country
- US
- [email protected]
- Phone
- 812 9863551
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lens, Spectacle (Prescription), For Reading Discomfort | NJH | Class 1 | Ophthalmic | No | 2020-12-08 |
| Spectacle, Magnifying | HOI | Class 1 | Ophthalmic | No | 2013-12-17 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2000-07-19 |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | Class 1 | Ophthalmic | No | 2020-12-08 |
| Frame, Spectacle | HQZ | Class 1 | Ophthalmic | No | 2016-07-28 |
| Lens, Prescription, Color Deficiency | NAI | Class 1 | Ophthalmic | No | 2020-12-08 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2015-10-29 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device