Optego
22 piece Prism Block Set, polymer case
6manufacturers in China registered for this device type
48catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Beijing (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| 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 Canton Optics Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 14 |
| Jiangsu Liangxu Intelligence Science AND Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 12 |
Record
| Listed by | Optego Vision USA, Inc., United States |
|---|---|
| FDA product code | HKW |
| Device type | Prism, Bar, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1650 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-11-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 936940 | In distribution | |
| 936910 | In distribution | |
| 936907 | In distribution | |
| 936935 | In distribution | |
| 92352 | In distribution | |
| 936725 | In distribution | |
| 936916 | In distribution | |
| 936715 | In distribution | |
| 936714 | In distribution | |
| 936914 | In distribution | |
| 936710 | In distribution | |
| 936908 | In distribution | |
| 936740 | In distribution | |
| 936706 | In distribution | |
| 936750 | In distribution | |
| 936712 | In distribution | |
| 936904 | In distribution | |
| 936920 | In distribution | |
| 936718 | In distribution | |
| 936703 | In distribution | |
| 936902 | In distribution | |
| 936704 | In distribution | |
| 936930 | In distribution | |
| 936708 | In distribution | |
| 936906 | In distribution | |
| 936701 | In distribution | |
| 936716 | In distribution | |
| 936700 | In distribution | |
| 936909 | In distribution | |
| 92354 | In distribution | |
| 936901 | In distribution | |
| 936915 | In distribution | |
| 936730 | In distribution | |
| 936735 | In distribution | |
| 936912 | In distribution | |
| 936905 | In distribution | |
| 936945 | In distribution | |
| 936707 | In distribution | |
| 936702 | In distribution | |
| 936900 | In distribution | |
| 936918 | In distribution | |
| 936925 | In distribution | |
| 936950 | In distribution | |
| 936709 | In distribution | |
| 936705 | In distribution | |
| 936720 | In distribution | |
| 936745 | In distribution | |
| 936903 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Visionix | Luneau Technology Operations | 4 |
| Clement Clarke Ophthalmic | Haag-Streit UK Ltd. | 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.