Keratograph 5m
The OCULUS Keratograph 5M combines the keratometric measuring process with topographic mapping. Measurement of the corneal surface is done by means of a Placido ring system that is…
The OCULUS Keratograph 5M combines the keratometric measuring process with topographic mapping. Measurement of the corneal surface is done by means of a Placido ring system that is reflected off the cornea. These data are analyzed by the computer.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Beijing (1), Shanghai (1), Chongqing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
| Shenzhen Certainn Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Ningbo FLO Optical Technology Development Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 4 |
Record
| Listed by | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | MMQ |
| Device type | Topographer, Corneal, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1350 |
| Premarket notification | Exempt |
| Record published | 2016-09-01 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -40 to 70 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 70 to 106 % RH; Handling environment temperature 10 to 35 °C; Handling environment humidity 30 to 90 % RH; Handling environment atmospheric pressure 80 to 106 KiloPascal |
| Sizes | Weight 6.1 kg; height 512 mm; depth 400 mm; width 275 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7700 | Weight 6.1 kg | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Topographic Modeling System | Tomey Corporation | 3 |
| Corneal Topographer | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2 |
| Mediworks | Shanghai Mediworks Precision Instruments Co., Ltd. | 2 |
| TearCheck T | E-Swin | 2 |
| Cassini | Cassini Technologies B.V. | 1 |
| Medmont Meridia Advanced Topographer Vantage | Medmont International PTY Ltd | 1 |
| Corneal Topographer HTG-1 | Huvitz Co., Ltd. | 1 |
| Tera Dry Eye Imager | Visia Imaging SRL | 1 |
| Moptim | Shenzhen Certainn Technology Co., Ltd. | 1 |
| Medmont Meridia Advanced Topographer Professional | Medmont International PTY Ltd | 1 |
| Medmont Meridia Advanced Topographer Classic | Medmont International PTY Ltd | 1 |
| Auto Ref-Topographer HRKT-1 | Huvitz Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.