FDA Registration
Active
🇺🇸 United States
CARL ZEISS MEDITEC INC
Reg #: 2918630
·
FEI: 2918630
·
Expires 2026
Products
14
Proprietary Names
41
Establishment Types
4
Classifications
14
Registration Details
- Registration Name
- CARL ZEISS MEDITEC INC
- Registration Number
- 2918630
- FEI Number
- 2918630
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5300 Central Parkway
- City
- DUBLIN
- State
- CA
- ZIP
- 94568
- Country
- US
Regulatory Submissions
- 510(k) Number
- K954167
Owner / Operator
- Firm Name
- Carl Zeiss Meditec AG (Jena)
- Operator Number
- 9053564
- Address
- Goeschwitzer Strasse 51-52
- City
- Jena
- State
- Thuringia
- Postal Code
- 07745
- Country
- DE
- Correspondent
- Carl ZEISS Meditec AG (Jena)
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Perimeter, Automatic, Ac-Powered | HPT | Class 1 | Ophthalmic | No | 2014-09-11 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2014-07-29 |
| Tomography, Optical Coherence | OBO | Class 2 | Ophthalmic | No | 2014-07-29 |
| Table, Instrument, Powered, Ophthalmic | HRJ | Class 1 | Ophthalmic | No | 2013-01-21 |
| Camera, Ophthalmic, Slit-Scanning | QER | Class 2 | Ophthalmic | No | 2019-02-05 |
| Ophthalmoscope, Laser, Scanning | MYC | Class 2 | Ophthalmic | No | 2009-09-02 |
| Ophthalmoscope, Ac-Powered | HLI | Class 2 | Ophthalmic | No | 2009-09-02 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2008-04-10 |
| System, Image Management, Ophthalmic | NFJ | Class 2 | Radiology | No | 2021-01-04 |
| Transilluminator, Ac-Powered | HJM | Class 2 | Ophthalmic | No | 2017-11-17 |
| Perimeter, Ac-Powered | HOO | Class 1 | Ophthalmic | No | 2009-02-19 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2019-03-08 |
| Photokeratoscope | HJA | Class 1 | Ophthalmic | No | 2015-01-27 |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2016-10-28 |
Proprietary Names
Humphrey Field Analyzer 3 (HFA3) Model: 830, 840, 850 860
CIRRUS Photo Models 600 and 800
Power Table Model AV 100
Power Table Model AV 220
Power Table Model HFA 230
Universal instrument table IT 760
Universal instrument table IT 760W.i
Universal instrument table IT 1060.i
Universal instrument table IT 1060
Universal instrument table IT 760.i
Universal instrument table IT 760 W
Power Table Model HFA 120
Power Table Model AV 120
Power Table Model HPT 120
Power Table Model CV-120
Power Table Model AV 240
Power Table Model CV-230
Power Table Model Stratus OCT
CLARUS Model 500
Nerve
Cirrus HD-OCT Model 6000
CLARUS (700)
Nerve Fiber Analyzer
Stratus OCT with RNFL Normative Database
Humphrey Optical Coherence Tomography (OCT) Scanner
VELARA Software
CIRRUS HD-OCT Model 500
CIRRUS HD-OCT Model 5000
Cirrus HD OCT
CLARUS Model 700
CIRRUS HD-OCT Model 400, 4000
CIRRUS HD-OCT Model 500, 5000
CIRRUS HD-OCT Model 6000
Humphrey Matrix Model 800
Humphrey FDT Model 710
CIRRUS HD-OCT 5000
CIRRUS HD-OCT 500
VELARA 200
Atlas model 9000
CIRRUS photo Models 600 and 800
Plex Elite Model 9000
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device