FDA Registration
Active
🇩🇪 Germany
CARL ZEISS VISION GMBH
Reg #: 9617474
·
FEI: 3002398337
·
Expires 2026
Products
17
Proprietary Names
37
Establishment Types
4
Classifications
17
Registration Details
- Registration Name
- CARL ZEISS VISION GMBH
- Registration Number
- 9617474
- FEI Number
- 3002398337
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Turnstrasse 27
- City
- AALEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K253834
Owner / Operator
- Firm Name
- CARL ZEISS VISION INC.
- Operator Number
- 9072118
- Address
- 1040 Worldwide Blvd
- City
- Hebron
- State
- KY
- Postal Code
- 41048
- Country
- US
- Correspondent
- Jahmal A Cannon
US Agent
- Business Name
- Carl Zeiss Vision Inc.
- Contact Name
- Jahmal Cannon
- Address
- 1040 Worldwide Blvd
- City
- Hebron
- State
- KY
- ZIP
- 41048
- Country
- US
- [email protected]
- Phone
- 423 5982680
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2017-12-19 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 1992-06-16 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 1999-01-21 |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | Class 1 | Ophthalmic | No | 2006-04-21 |
| Distometer | HMM | Class 1 | Ophthalmic | No | 2012-02-21 |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 2019-03-21 |
| Table, Instrument, Powered, Ophthalmic | HRJ | Class 1 | Ophthalmic | No | 2023-06-02 |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2026-03-19 |
| Stand, Instrument, Ac-Powered, Ophthalmic | HMF | Class 1 | Ophthalmic | No | 2020-02-19 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2013-06-27 |
| Telescope, Spectacle, Low-Vision | HKK | Class 1 | Ophthalmic | No | 1999-01-21 |
| Frame, Spectacle | HQZ | Class 1 | Ophthalmic | No | 1992-06-16 |
| Instrument, Measuring, Lens, Ac-Powered | HLM | Class 1 | Ophthalmic | No | 2019-06-24 |
| Tonometer, Ac-Powered | HKX | Class 2 | Ophthalmic | No | 2019-07-26 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2025-04-02 |
| Pupillometer, Ac-Powered | HLG | Class 1 | Ophthalmic | No | 2025-11-20 |
| Chair, Ophthalmic, Ac-Powered | HME | Class 1 | Ophthalmic | No | 2019-07-26 |
Proprietary Names
VISU360
VISUCONSULT 500
ATLAS Review for i.Profiler plus
ZEISS SUNGLASSES
VISUSCREEN 500
VISUSCREEN 100
VISUSCREEN 100 Compact
CARL ZEISS VISION LENS
ZEISS SPECTACLE LENSES
ZEISS Single Vision Individual
1.5
1.53
1.67 Optics
ZEISS Optical Insert
1.74
i.Terminal go
i.Terminal Mobile
VISUFIT 1000
i.Terminal 2
VISUPHOR 500
VISUCORE 500 Table
VISUREF 600
i.Terminal 2 Station
VISUFIT 1000 Platform
VISUREF 150
i.Profiler plus
VISUREF
VISUCORE 500 Refractor
Low - vision
Spectical Frames / lens
VISULENS 550
VISUPLAN 500
VISUREF 1000
ZEISS Mobile Centration
Slit lamps
VISUSCOUT 100
Chair & Stand
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device
Complaint File Establishment per 21 CFR 820.198