FDA.reportPublic FDA data

QUEX ED

Primary DI
05999860882060
Brand
QUEX ED
Company
QX WORLD LTD
Model
Hardware V2.6
Device description
This is the hardware component of the QUEX ED system.The system provides the following functions: Two-channel EEG, GSR
Published
2026-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZODevice, Galvanic Skin Response Measurement
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZODevice, Galvanic Skin Response MeasurementNeurology2
OMCReduced- Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232779000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232779000QUEX ED; QUEX SQx World, Ltd.2024-10-11OMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05999860882060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05999860882060059998608820605999860882060

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographAn electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

Regulatory Flags#

DUNS number
401560903
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05999860882046QUEX EDSystem2026-04-27
05999860882053QUEX SSystem2026-04-27
05999860882077QUEX SHardware V1.4.22026-04-27
05999860882015QUEX-EDNA2021-07-08
05990804321003QUEX-EDNA2021-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011306314ATLAS Cart - Dual MonitorsNEURALYNX, INC.OMC2026-04-27
05999860882046QUEX EDQX WORLD LTDGZO2026-04-27
05999860882046QUEX EDQX WORLD LTDOMC2026-04-27
05999860882053QUEX SQX WORLD LTDOMC2026-04-27
05999860882053QUEX SQX WORLD LTDGZO2026-04-27
05999860882077QUEX SQX WORLD LTDOMC2026-04-27
05999860882077QUEX SQX WORLD LTDGZO2026-04-27
B566847020ZmachineGeneral SleepOMC2026-04-16
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B566847001ZmachineGeneral SleepOMC2026-04-09
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09342451002822Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002860Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451007063Compumedics Somfit DCOMPUMEDICS LIMITEDOMC2026-03-12
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