Device
The QUEX ED device is an electrophysiological system with EEG and GSR functions.
Manufacturer
QX WORLD LTD
QX WORLD LTD
Model: System
DI: 05999860882046
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
The QUEX ED device is an electrophysiological system with EEG and GSR functions.
The main related components are identified as follows:
QUEX Monitor software (version 1.0.0.10) and QUEX ED Hardware V2.6.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
350a2888-8cb1-4680-86bb-c4eb449cab4c
Distribution Status:
In Commercial Distribution
DUNS Number:
401560903
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05999860882046
Type:
Primary
Issuing Agency:
GS1
GMDN
Code:
Name:
FDA Product Codes
OMC
Reduced- Montage Standard Electroencephalograph
GZO
Device, Galvanic Skin Response Measurement
Premarket Submissions
Submission Number:
K232779
Supplement Number:
000