Device
The QUEX S device is an electrophysiological system with EEG and GSR functions.
Manufacturer
QX WORLD LTD
Model: System DI: 05999860882053 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 S 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 S Hardware V 1.4.2.
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: f8df65f8-a0f5-4b06-a1c9-55d1d9910497
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: 05999860882053
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