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Catalogue number 80000, listed by Oculus Optikgeräte Gesellschaft mit beschränkter Haftung, under Tester, Color Vision. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gino Optical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Ningbo Ming Sing Optical R&D Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 9 |
Record
| Listed by | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | HIT |
| Device type | Tester, Color Vision |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1170 |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 80000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Virtual Eye Software | Virtual Vision Health | 5 |
| Computerized vision tester | Ningbo Ming Sing Optical R&D Co., Ltd. | 2 |
| bili-ruler | Little Sparrows Technologies Inc | 1 |
| NeuroColor | AMA Optics, Inc. | 1 |
| Tester, Color Vision | Konan Medical USA, Inc. | 1 |
| Virtual Eye PRO | Virtual Vision Health | 1 |
| Virtual Eye Elite S | Virtual Vision Health | 1 |
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.