Visuscreen 100
Catalogue number 000000-2069-910, listed by Carl Zeiss Vision Gmbh, Germany, under Chart, Visual Acuity. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (5), Chongqing (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| DU-Hope International Group | Nanjing | Jiangsu | Contract manufacturer | 11 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| 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 |
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| 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 |
| MDF Instruments Medifriend Inc. | Song Jiang District | Shanghai | Repacker / relabeller | 13 |
| Jiangsu Liangxu Intelligence Science AND Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 12 |
Showing 12 of 21. All 21 manufacturers in China registered for Chart, Visual Acuity
Record
| Listed by | Carl Zeiss Vision Gmbh, Germany |
|---|---|
| FDA product code | HOX |
| Device type | Chart, Visual Acuity |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1150 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-01-01 |
| Record revised | 2021-01-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 85 % RH; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -20 to 70 °C; Handling environment temperature 10 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000000-2069-910 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Visual Chart System | View-M Technology Co., Ltd. | 9 |
| VT1 | FIM Medical | 8 |
| Visionix | Luneau Technology Operations | 5 |
| AMA Optics Eye Chart | AMA Optics, Inc. | 5 |
| Lambda 100 | Heine Optotechnik Gmbh & Co. KG. | 4 |
| AMA Optics Retinometer | AMA Optics, Inc. | 4 |
| Yeasn | Chongqing Yeasn Science-Technology Co., Ltd. | 3 |
| Optego | Optego Vision USA, Inc. | 3 |
| Topcon | Visia Imaging SRL | 3 |
| Self Vision Tester | View-M Technology Co., Ltd. | 2 |
| Chart Projector | Nidek Incorporated | 2 |
| NearBright | Reichert Inc. | 2 |
Showing 12 of 60. All products under Chart, Visual Acuity
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.