FDA Registration
Active
🇮🇩 Indonesia
PT. CIBA VISION BATAM
Reg #: 9681121
·
FEI: 3002807944
·
Expires 2026
Products
13
Proprietary Names
0
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- PT. CIBA VISION BATAM
- Registration Number
- 9681121
- FEI Number
- 3002807944
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- JL BERINGIN LOT No. 204, BATAMINDO INDUSTRIAL PARK, MUKA KUNING
- City
- BATAM ISLAND Riau
- Country
- ID
Regulatory Submissions
- 510(k) Number
- K181796
- PMA Number
- P930014
Owner / Operator
- Firm Name
- Alcon Laboratories, Inc.
- Operator Number
- 1610287
- Address
- 6201 South Freeway
- City
- Fort Worth
- State
- TX
- Postal Code
- 76134
- Country
- US
US Agent
- Business Name
- ALCON LABORATORIES, INC.
- Contact Name
- Dale Schaper
- Address
- 6201 SOUTH FREEWAY
- City
- Fort Worth
- State
- TX
- ZIP
- 76134
- Country
- US
- [email protected]
- Phone
- 817 5686421
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lenses, Soft Contact, Daily Wear | LPL | Class 2 | Ophthalmic | No | 2019-08-22 |
| Extended Depth Of Focus Intraocular Lens | POE | Class 3 | Ophthalmic | No | 2007-11-21 |
| Lens, Multifocal Intraocular | MFK | Class 3 | Ophthalmic | No | 2007-11-21 |
| Intraocular Lens | HQL | Class 3 | Ophthalmic | No | 2007-11-21 |
| Lens, Intraocular, Toric Optics | MJP | Class 3 | Ophthalmic | No | 2007-11-21 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2012-04-19 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | Class 2 | Ophthalmic | No | 2012-04-19 |
| Photocoagulator And Accessories | HQB | Class 2 | Ophthalmic | No | 2012-04-19 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2012-04-19 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2024-04-03 |
| Lenses, Soft Contact, Extended Wear | LPM | Class 3 | Ophthalmic | No | 2013-10-30 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2008-04-09 |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | Class 1 | Ophthalmic | No | 2004-02-10 |
Establishment Types
Manufacture Medical Device