NeurOptics
Box of 24 Smart Guards
1manufacturer
10catalogue 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 | Neuroptics, Inc., United States |
|---|---|
| FDA product code | HLG |
| Device type | Pupillometer, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1700 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-03-11 |
| Record revised | 2024-03-22 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -38 to 70 °C; Storage environment humidity 10 to 95 % RH |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PLR-4000 Pupilometer System | In distribution | |
| VIP-400 Pupillometer System | In distribution | |
| VIP4-CHG Charging Station | In distribution | |
| SG-200 | In distribution | |
| CHG-300 Charger | In distribution | |
| VIP-400 Pupillometer | In distribution | |
| NPi-300 Pupilometer | In distribution | |
| PLR-4000 Pupillometer | In distribution | |
| NPi-300 Pupilometer System | In distribution | |
| NPi-200 System | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RETeval™ | L K C Technologies, Inc. | 12 |
| 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.