Mediworks
Corneal topography system
5manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Shanghai Mediworks Precision Instruments Co., Ltd., China |
|---|---|
| FDA product code | MMQ |
| Device type | Topographer, Corneal, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1350 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-02 |
| Record revised | 2026-02-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DEA520 | In distribution | |
| Scansys TA517 | 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 |
| 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 |
| Keratograph 5M | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 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.