AKR 800
AKR800 is intended to objectively measure the refractive power of the eye and to measure the corneal curvature radii.
17manufacturers in China registered for this device type
1catalogue number
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 | Essilor International, France |
|---|---|
| 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 | 2026-02-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature -20 to 60 °C; Storage environment temperature -40 to 70 °C; Handling environment humidity 10 to 90 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AKR1JR | 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.