Topographic Modeling System
with 31 cone
5manufacturers in China registered for this device type
3catalogue 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 | Tomey Corporation, Japan |
|---|---|
| FDA product code | MMQ |
| Device type | Topographer, Corneal, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1350 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-10-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TMS-4N | In distribution | |
| TMS-4N | In distribution | |
| TMS-4N | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.