Vision-R 700
Vision-R 700 is intended to perform a subjective assessment of ametropia or visual function capability
15manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Essilor International, France |
|---|---|
| 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 | 2023-09-11 |
| Record revised | 2023-09-29 (version 2) |
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 70 to 106 KiloPascal; Handling environment temperature -40 to 70 °C; Handling environment humidity 10 to 95 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -10 to 55 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V01112 | In distribution | |
| V01114 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Yeasn | Chongqing Yeasn Science-Technology Co., Ltd. | 9 |
| Moptim | Shenzhen Certainn Technology Co., Ltd. | 4 |
| S4Optik | Innova Medical Ophthalmics | 3 |
| Refractor | Nidek Incorporated | 3 |
| Lombart | Innova Medical Ophthalmics | 3 |
| 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.