FDA Registration
Active
🇨🇳 China
OBJECTT OPTIK COMPANY LIMITED
Reg #: 8040277
·
FEI: 3005939549
·
Expires 2026
Products
8
Proprietary Names
8
Establishment Types
5
Classifications
8
Registration Details
- Registration Name
- OBJECTT OPTIK COMPANY LIMITED
- Registration Number
- 8040277
- FEI Number
- 3005939549
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- FLAT C, 5/F., HOP SHI FACTORY BUILDING,, NO. 22-24 CHEUNG LEE STREET, CHAI WAN
- City
- HONG KONG
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K113703
- PMA Number
- P040045
Owner / Operator
- Firm Name
- OBJECTT OPTIK COMPANY LIMITED
- Operator Number
- 8040277
- Address
- FLAT C, 5/F., HOP SHI FACTORY BUILDING, NO 22-24 CHEUNG LEE STREET, CHAI WAN
- City
- HONG KONG
- State
- HK-NOTA
- Postal Code
- ---
- Country
- HK
- Correspondent
- LAK - CHEONG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lenses, Soft Contact, Daily Wear | LPL | Class 2 | Ophthalmic | No | 2020-07-23 |
| Lens, Contact, (Disposable) | MVN | Class 2 | Ophthalmic | No | 2020-07-23 |
| Papers, Ion | DMG | Class 1 | Clinical Chemistry | No | 2020-07-29 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2020-08-07 |
| Lenses, Soft Contact, Extended Wear | LPM | Class 3 | Ophthalmic | No | 2020-07-23 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 1983-06-06 |
| Frame, Spectacle | HQZ | Class 1 | Ophthalmic | No | 1983-06-08 |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | Class 1 | Ophthalmic | No | 2011-06-01 |
Proprietary Names
Contact Lens
PROGEAR ANTI FOG GEL
PROGEAR ANTI FOG LENS CLEANING WIPE
CONTACT LENS
PROGEAR
E-OPTICIAN
FREE FORM GREEN
RAPALA
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device