Infrared Communication Unit
Catalogue number INFRARED COMMUNICATION UNIT, listed by Topcon Corp., Japan, under Refractor, Manual, Non-Powered, Including Phoropter. 15 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
| Chongqing Yeasn Science-Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 5 |
| Langfang FAR East Prosperous Optical Instrument Co., Ltd. | Langfang | Hebei | Contract manufacturer | 5 |
| 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 |
| 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 |
| Ningbo Ming Sing Optical R&D Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 9 |
Showing 12 of 15. All 15 manufacturers in China registered for Refractor, Manual, Non-Powered, Including Phoropter
Record
| Listed by | Topcon Corp., Japan |
|---|---|
| FDA product code | HKN |
| Device type | Refractor, Manual, Non-Powered, Including Phoropter |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1770 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-08-31 |
| Record revised | 2023-09-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| INFRARED COMMUNICATION UNIT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Yeasn | Chongqing Yeasn Science-Technology Co., Ltd. | 9 |
| Moptim | Shenzhen Certainn Technology Co., Ltd. | 4 |
| S4Optik | Innova Medical Ophthalmics | 3 |
| Refractor | Nidek Incorporated | 3 |
| Lombart | Innova Medical Ophthalmics | 3 |
| Vision-R 700 | Essilor International | 2 |
| Phoropter VRx | Reichert Inc. | 2 |
| Power Supply Unit for CV-5000 (Built-IN PC Type) | Topcon Corp. | 2 |
| Compu Vision CV-5000 | Topcon Corp. | 2 |
| Illuminated Phoropter | Reichert Inc. | 2 |
| Vision-R 800 | Essilor International | 2 |
| Visionix | Luneau Technology Operations | 2 |
Showing 12 of 40. All products under Refractor, Manual, Non-Powered, Including Phoropter
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.