The digital Corneal Reflection Pupillometer (CRP) enables the Eyecare professional to obtain a measurement of a patient's monocular and binocular pupillary distance and displays them…
The digital Corneal Reflection Pupillometer (CRP) enables the Eyecare professional to obtain a measurement of a patient’s monocular and binocular pupillary distance and displays them digitally.
Who Else Makes It
Registered in Shaanxi. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Digital C.R.P | Listed by | Essilor International, France |
| FDA product code | HLG |
| Device type | Pupillometer, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1700 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-04-09 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 35 °C; Handling environment humidity 30 to 90 % RH; Storage environment temperature -10 to 55 °C; Storage environment humidity 10 to 95 % RH |
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.