Pupilometer
Measure the distance between the pupils of human eye.
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (3), 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 |
|---|---|---|---|---|
| Shanghai Lucidarx Optical LLC | Shanghai | Shanghai | Contract manufacturer | 9 |
| Chongqing Yeasn Science-Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 5 |
| 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 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| 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 |
Record
| Listed by | Chongqing Yeasn Science-Technology Co., Ltd., China |
|---|---|
| FDA product code | HLH |
| Device type | Pupillometer, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1700 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-10-22 |
| Record revised | 2024-08-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Distribution end date | 2022-08-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HX-400 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Yeasn | Chongqing Yeasn Science-Technology Co., Ltd. | 2 |
| Advancing Eyecare | Lombart Brothers, Inc. | 1 |
| S4Optik | Innova Medical Ophthalmics | 1 |
| PDM Digital PD Meter | Reichert Inc. | 1 |
| PD-1 | Innova Medical Ophthalmics | 1 |
| Lombart | Innova Medical Ophthalmics | 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.