Ultramatic RX Master Phoropter
2 catalogue numbers from 11635B, listed by Reichert Inc., United States, 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 | Reichert Inc., United States |
|---|---|
| FDA product code | HKN |
| Device type | Refractor, Manual, Non-Powered, Including Phoropter |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1770 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-08-12 |
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 |
|---|---|---|
| 11635B | In distribution | |
| 11625B | 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
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-02-28 | Class II | Process control | The head of the phoropter head could come loose and potentially detach due to a default in the assembly. | 1876 units |
| 2025-02-28 | Class II | Process control | The head of the phoropter head could come loose and potentially detach due to a default in the assembly. | 122 units |
| 2023-07-20 | Class II | Device Design | Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If the Phoroptor VRx Head detaches from the bracket, it can fall onto a patient or device operator | 53 units; Extended 34 units |
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.