FDA Registration
Active
🇭🇰 Hong Kong
POLETTE LIMITED
Reg #: 3017774717
·
FEI: 3017774717
·
Expires 2026
Products
9
Proprietary Names
24
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- POLETTE LIMITED
- Registration Number
- 3017774717
- FEI Number
- 3017774717
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18/F, 33 Wyndham Street, Central
- City
- Hong Kong
- Country
- HK
Owner / Operator
- Firm Name
- Polette Limited
- Operator Number
- 10092712
- Address
- 18/F, 33 Wyndham Street, Central
- City
- Hong Kong
- State
- HK-NOTA
- Postal Code
- 999077
- Country
- HK
- Correspondent
- Coco Chen
US Agent
- Business Name
- Hyun Turle E-Commerce Inc
- Contact Name
- jimmy chen
- Address
- 327 S Orange Ave
- City
- Monterey Park
- State
- CA
- ZIP
- 91755
- Country
- US
- [email protected]
- Phone
- 626 6273399
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lens, Spectacle (Prescription), For Reading Discomfort | NJH | Class 1 | Ophthalmic | No | 2025-02-09 |
| Frame, Trial, Ophthalmic | HPA | Class 1 | Ophthalmic | No | 2025-02-09 |
| Spectacle, Magnifying | HOI | Class 1 | Ophthalmic | No | 2025-02-09 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2025-02-09 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2025-02-09 |
| Pupillometer, Manual | HLH | Class 1 | Ophthalmic | No | 2025-02-09 |
| Frame, Spectacle | HQZ | Class 1 | Ophthalmic | No | 2025-02-09 |
| Set, Lens, Trial, Ophthalmic | HPC | Class 1 | Ophthalmic | No | 2025-02-09 |
| Selector, Color, Spectacle, Lens, Tint | NFD | Class 1 | Ophthalmic | No | 2025-02-09 |
Proprietary Names
Lens, Spectacle (Non-Prescription, Sports Performance)
Lens, Spectacle (Prescription, Photochromic)
Lens, Spectacle (Prescription, Sports Performance)
Lens, Spectacle (Non-Prescription, Polarised)
Lens, Spectacle (Prescription, Mirrored)
Lens, Spectacle (Prescription, for Reading Discomfort)
Lens, Spectacle (Non-Prescription, Mirrored)
Lens, Spectacle (Non-prescription, Photochromic)
Lens, Spectacle (Non-Prescription, Eye Protection)
Lens, Spectacle (Non-Prescription, Blue Light Filtering)
Lens, Spectacle (Non-prescription, for Reading Discomfort)
Lens, Spectacle (Prescription, Blue Light Filtering)
Lens, Spectacle (Prescription, Eye Protection)
Lens, Spectacle (Prescription, Polarised)
Trial Frame
Spectacle, Magnifying (Non-Prescription Reading Glasses)
Ski Goggle
Lens Wipe
PD Machine
Frame, Spectacle (Sports Frame)
Frame, Spectacle Titanium Frame
Trial lens set
Color Tinted Lens (Non-prescription)
Color Tinted Lens (Prescription)
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