Moptim
The Handheld Auto Refractometer uses the infrared fundus reflection phase method to emit a beam of infrared light with a specific wavelength, through the subject's cornea, lens, etc., and…
The Handheld Auto Refractometer uses the infrared fundus reflection phase method to emit a beam of infrared light with a specific wavelength, through the subject’s cornea, lens, etc., and finally projected to the eye retina, and then reflected back to the corresponding optical system of the instrument. The image is taken through the image sensor, and the spherical refraction power, cylindrical refraction power and astigmatism axis are calculated after image processing and signal processing, which is used to determine the refractive state of human eyes.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
| Chongqing Yeasn Science-Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 5 |
| Langfang FAR East Prosperous Optical Instrument Co., Ltd. | Langfang | Hebei | Contract manufacturer | 5 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Danyang NEW Hope Medical Equipment Co., Ltd. | Danyang | Jiangsu | Manufacturer | 38 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Gino Optical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Shanghai Canton Optics Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 14 |
| Ningbo Ming Sing Optical R&D Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 9 |
Showing 12 of 15. All 15 manufacturers in China registered for Refractor, Manual, Non-Powered, Including Phoropter
Record
| Listed by | Shenzhen Certainn Technology Co., Ltd., China |
|---|---|
| FDA product code | HKN |
| Device type | Refractor, Manual, Non-Powered, Including Phoropter |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1770 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-06-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 55 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 10 to 35 °C; Handling environment humidity 30 to 90 % RH; Handling environment atmospheric pressure 80 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| easyRef Pro | In distribution | |
| R3X | In distribution | |
| easyRef | In distribution | |
| R2X | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Yeasn | Chongqing Yeasn Science-Technology Co., Ltd. | 9 |
| S4Optik | Innova Medical Ophthalmics | 3 |
| Refractor | Nidek Incorporated | 3 |
| Lombart | Innova Medical Ophthalmics | 3 |
| Vision-R 700 | Essilor International | 2 |
| Phoropter VRx | Reichert Inc. | 2 |
| Power Supply Unit for CV-5000 (Built-IN PC Type) | Topcon Corp. | 2 |
| Compu Vision CV-5000 | Topcon Corp. | 2 |
| Illuminated Phoropter | Reichert Inc. | 2 |
| Vision-R 800 | Essilor International | 2 |
| Visionix | Luneau Technology Operations | 2 |
| Eli Ezer | U.S. Ophthalmic, L.L.C. | 2 |
Showing 12 of 40. All products under Refractor, Manual, Non-Powered, Including Phoropter
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.