Fresnel Prism AND Lens
SET, Lens, Trial, Fresnel Prism, NO Handles, 12 - 40 Diopter
13manufacturers in China registered for this device type
32catalogue numbers in this listing
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 | Fresnel Prism & Lens Co., United States |
|---|---|
| FDA product code | HPC |
| Device type | Set, Lens, Trial, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1405 |
| Establishment | Reprocessor, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-03-29 |
| Record revised | 2021-05-27 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4000-10NH | In distribution | ||
| 4000-3 | In distribution | ||
| 4000-2NH | In distribution | ||
| 4000-20 | In distribution | ||
| 4000-6 | In distribution | ||
| 4000-2 | In distribution | ||
| 4000NH | 7 | In distribution | |
| 4000-20NH | In distribution | ||
| 4000-4NH | In distribution | ||
| 5000 | 7 | In distribution | |
| 4000 | 7 | In distribution | |
| 4000-8NH | In distribution | ||
| 4000-10 | In distribution | ||
| 4000-15 | In distribution | ||
| 4000-8 | In distribution | ||
| 5000NH | 7 | In distribution | |
| 4000-35NH | In distribution | ||
| 4000-6NH | In distribution | ||
| 4000-25NH | In distribution | ||
| 4000-40NH | In distribution | ||
| 4000-12 | In distribution | ||
| 4000-5 | In distribution | ||
| 4000-5NH | In distribution | ||
| 4000-40 | In distribution | ||
| 4000-12NH | In distribution | ||
| 4000-3NH | In distribution | ||
| 4000-30NH | In distribution | ||
| 4000-30 | In distribution | ||
| 4000-25 | In distribution | ||
| 4000-15NH | In distribution | ||
| 4000-4 | In distribution | ||
| 4000-35 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bernell | Bernell | 175 |
| Optego | Optego Vision USA, Inc. | 66 |
| 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 X/O (according to Kochniss), without convex cylinders, coated, inclusive tria | 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.