NL-2-DEM

NeuroLight kit for demonstration (NeuroLight portable pupillometer NL-MU, wireless charging station STA-W2, 10 eyecups EMB-NL, power supply PWR5-1_US, user manual and robust demonstration…

Registry build 21.09.26

NeuroLight kit for demonstration (NeuroLight portable pupillometer NL-MU, wireless charging station STA-W2, 10 eyecups EMB-NL, power supply PWR5-1_US, user manual and robust demonstration case)

1manufacturer
1catalogue number

Who Else Makes It

Registered in Shaanxi. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HLG
Manufacturer City Province Registered as Device types
Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) Taiyuan Shaanxi Contract manufacturer 14

Record

Regulatory record for NL-2-DEM
Listed by Idmed Corp., United States
FDA product code HLG
Device type Pupillometer, Ac-Powered
Device class Class 1
Regulation 21 CFR 886.1700
Establishment Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-06-10

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Supplied as a kit Yes
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for NL-2-DEM
Catalogue number Size Status
NL-2-DEM In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
RETeval™ L K C Technologies, Inc. 12
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
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer