BK X/O (According to Kochniss), Without Convex Cylinders, Coated, Inclusive Tria
BK X/O (according to Kochniss), without convex cylinders, coated, inclusive trial lens case
13manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
| Update Optical Manufacturer Limited | Longgang District, Shenzhen | Guangdong | Contract manufacturer | 3 |
| 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 Canton Optics Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 14 |
| Jiangsu Liangxu Intelligence Science AND Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 12 |
| Wenzhou Hala Trade Co., Ltd. | Wenzhuo | Zhejiang | Manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Set, Lens, Trial, Ophthalmic
Record
| Listed by | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | HPC |
| Device type | Set, Lens, Trial, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1405 |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
| Record revised | 2024-09-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature -10 to 55 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Distribution end date | 2024-03-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 33101 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bernell | Bernell | 175 |
| Optego | Optego Vision USA, Inc. | 66 |
| Fresnel Prism AND Lens | Fresnel Prism & Lens Co. | 32 |
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 9 |
| Rexxam | Rexxam.co., Ltd. | 2 |
| BK S2, wooden case with handle | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| BK 2, coated, wooden case with handle | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| BK S1/T without convex cylinders, coated table version, trial lens case | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| BK 2, without convex cylinders, wooden case with handle | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| BK S3, wooden lens case with handle | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Prism Lens Case, coated | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| BK S1/T without convex cylinders, table version, trial lens case | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
Showing 12 of 39. All products under Set, Lens, Trial, 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.