RETeval™
RETeval visual electrophysiology system - Complete Model for Ukraine only
1manufacturer
12catalogue numbers in this listing
Who Else Makes It
Registered in Shaanxi. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
Record
| Listed by | L K C Technologies, Inc. |
|---|---|
| FDA product code | HLG |
| Device type | Pupillometer, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1700 |
| 510(k) | K142567 |
| Record published | 2025-07-01 |
| Record revised | 2024-03-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2024-08-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RETeval-DR – ROW | In distribution | |
| RETeval Complete – UKRAINE | In distribution | |
| RETeval Complete | In distribution | |
| RETeval Complete | In distribution | |
| RETeval Complete | In distribution | |
| RETeval Flicker | In distribution | |
| RETeval Complete USA | In distribution | |
| RETeval-DR | Withdrawn | |
| RETeval Complete w/o Electrodes | Withdrawn | |
| RETeval Complete | Withdrawn | |
| RETeval Complete w/o Electrodes | Withdrawn | |
| RETeval S | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NeurOptics | Neuroptics, Inc. | 10 |
| STA-W2 | Idmed Corp. | 1 |
| NL-2 | Idmed Corp. | 1 |
| Vissard 3D, linear polarized | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| NL-2-DEM | Idmed Corp. | 1 |
| Zeiss Mobile Centration | Carl Zeiss Vision Gmbh | 1 |
| NL-MU | Idmed Corp. | 1 |
| Digital C.R.P | Essilor International | 1 |
| Vissard 3D, circular polarized | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Vissard RG | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| PD Meter | Nidek Incorporated | 1 |
| Vision Monitor – MonColor | Metrovision SAS | 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.