Moptim
The ARK-A1 utilizes the infrared light retinal reflection phase method. It emits a specific wavelength of infrared light that passes through the cornea, lens, and other parts of the eye,…
The ARK-A1 utilizes the infrared light retinal reflection phase method. It emits a specific wavelength of infrared light that passes through the cornea, lens, and other parts of the eye, ulti-mately projecting onto the retina. The light is then reflected back into the instrument’s optical system. The image is captured by an image sensor and, after image processing and signal pro-cessing, the spherical lens power, cylindrical lens power, and cylindrical axis are calculated. This instrument is used to measure the refractive status of the human eye.
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (4), Beijing (2). 2 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 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| 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 Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
| Ningbo Ming Sing Optical R&D Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 9 |
| Shenzhen Certainn Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Chongqing Yeasn Science-Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 5 |
Showing 12 of 17. All 17 manufacturers in China registered for Refractometer, Ophthalmic
Record
| Listed by | Shenzhen Certainn Technology Co., Ltd., China |
|---|---|
| FDA product code | HKO |
| Device type | Refractometer, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1760 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-06-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature 5 to 40 °C; Handling environment humidity 0 to 80 % RH; Handling environment atmospheric pressure 86 to 106 KiloPascal; Storage environment temperature -20 to 55 °C; Storage environment humidity 0 to 93 % RH; Storage environment atmospheric pressure 86 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ARK-A1 | In distribution | |
| iRef | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Righton | Right MFG. Co., Ltd. | 27 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 13 |
| Visionix | Right MFG. Co., Ltd. | 13 |
| Auto REF/Keratometer | Ningbo Ming Sing Optical R&D Co., Ltd. | 6 |
| Microclear | Suzhou Microclear Medical Instruments Co., Ltd. | 6 |
| Rexxam | Rexxam.co., Ltd. | 5 |
| Auto Refractometer | Nidek Incorporated | 4 |
| plusoptiX 12 | Plusoptix Gmbh | 4 |
| Auto Refkeratometer | Tomey Corporation | 4 |
| MediWorks | Shanghai Mediworks Precision Instruments Co., Ltd. | 3 |
| Auto Refractometer RM-800 | Topcon Corp. | 3 |
| Yeasn | Chongqing Yeasn Science-Technology Co., Ltd. | 3 |
Showing 12 of 52. All products under Refractometer, Ophthalmic
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.