FDA Registration
Active
🇹🇷 Türkiye
ZUMRUT LENS SAGLIK HIZM. VE OPTIK UR. DIS. TIC. LTD. STI.
Reg #: 3036689755
·
FEI: 3036689755
·
Expires 2026
Products
4
Proprietary Names
43
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ZUMRUT LENS SAGLIK HIZM. VE OPTIK UR. DIS. TIC. LTD. STI.
- Registration Number
- 3036689755
- FEI Number
- 3036689755
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- HOBYAR MAH. KASTELLI IS MERKEZI
- City
- FATIH Istanbul
- Country
- TR
Regulatory Submissions
- 510(k) Number
- K182782
- PMA Number
- P980006
Owner / Operator
- Firm Name
- ZUMRUT LENS SAGLIK HIZM. VE OPTIK UR. DIS. TIC. LTD. STI.
- Operator Number
- 10092704
- Address
- HOBYAR MAH. KASTELLI IS MERKEZI
- City
- FATIH
- State
- Istanbul
- Postal Code
- 34112
- Country
- TR
US Agent
- Business Name
- Liberty Management Group Ltd.
- Contact Name
- Manoj Zacharias
- Address
- 75 Executive Drive,, Suite 114,
- City
- Aurora
- State
- IL
- ZIP
- 60504
- Country
- US
- [email protected]
- Phone
- 630 2702921
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | Class 2 | Ophthalmic | No | 2025-07-25 |
| Lenses, Soft Contact, Daily Wear | LPL | Class 2 | Ophthalmic | No | 2025-07-25 |
| Control Material, Her-2/Neu, Immunohistochemistry | NJW | Class 2 | Hematology | No | 2025-12-03 |
| Lenses, Soft Contact, Extended Wear | LPM | Class 3 | Ophthalmic | No | 2026-01-20 |
Proprietary Names
DAILIES TOTAL1, DAILIES TOTAL1 Asphere
DAILIES TOTAL1 Multifocal Toric
DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal
Biotrue ONEday for Astigmatism with NaturMoist
Biotrue ONEday for Presbyopia with NaturMoist
BIOTRUE ONE DAY (NESOFILCON A) Soft Contact Lenses
Biotrue ONEday with NaturMoist
PROCLEAR 1DAY, PROCLEAR XC
PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL
Bausch + Lomb (kalifilcon A
Bausch + Lomb (kalifilcon A) for Astigmatism
Bausch + Lomb (kalifilcon A) for Presbyopia
Acuvue 2; Acuvue Oasys Max 1-Day
ACUVUE OASYS MAX 1-Day MULTIFOCAL
1 Day Acuvue Define; 1 Day Acuvue Moist
1 Day Acuvue Moist For Astigmatism
ACUVUE OASYS with HydraLuxe
Acuvue Oasys For Presbyopia
Acuvue Oasys For Astigmatism
ACUVUE OASYS 1-Day with HydraLuxe
Acuvue Oasys Multifocal
PUREVISION 2; PureVision 2 for Astigmatism; PureVision 2 for Presbyopia
Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism
SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
ACUVUE® VITA 12 pack
ACUVUE® VITA (senofilcon C) Brand (Soft) Contact Lens
ACUVUE® VITA (senofilcon C) Brand (Soft) Contact Lens for ASTIGMATISM
ACUVUE® VITA 6 pack
Bausch + Lomb ULTRA Multifocal Toric
Bausch + Lomb ULTRA
Bausch + Lomb ULTRA for Astigmatism
Bausch + Lomb ULTRA for Presbyopia
Acuvue Oasys Max 1-day
ACUVUE OASYS MAX 1-Day ASTIGMATISM
AIR OPTIX Plus HydraGlyde Multifocal; AIR OPTIX Plus HydraGlyde Multifocal Toric
AIR OPTIX Plus HydraGlyde; AIR OPTIX Plus HydraGlyde For Astigmatism
Clariti 1 Day; Clariti 1 Day Multifocal; Clariti 1 Day Toric
DAILIES AQUACOMFORT PLUS MULTIFOCAL
DAILIES AQUACOMFORT PLUS
DAILIES AQUACOMFORT PLUS TORIC
Biofinity; Biofinity Energys
Biofinity Multifocal; Biofinity Toric
Precision1TM
Establishment Types
Export Device to the United States But Perform No Other Operation on Device