EyeBOX

Primary DI
00810051680010
Brand
EyeBOX
Company
Oculogica Inc.
Model
DMR-0004
Published
2026-05-19
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
QEABrain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEABrain Injury Adjunctive Interpretive Oculomotor Assessment AidNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242116000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242116000EyeBOX EBX-4.1Oculogica, Inc.2025-04-04QEA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810051680010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810051680010008100516800108100516800100810051680010

GMDN Terms#

Term, Definition table
TermDefinition
Eye-tracking neurological/brain injury assessment deviceAn electrically-powered unit intended to measure and analyse eye movement to assist in the diagnosis/assessment of a neurological disorder [e.g., autism spectrum disorder (ASD), attention-deficit hyperactivity disorder (ADHD), dementia] or potential traumatic brain injury (e.g., concussion). It includes visual stimuli (e.g., videos) and devices for sensing/tracking eye movement (e.g., infrared cameras), dedicated software for analysing results and providing management guidelines, and a user interface for viewing/input. It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device.

Regulatory Flags#

DUNS number
078866200
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810051680003EyeBOXOCL 02.52021-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013612900EYE-SYNCNEUROSYNC INC.QEA2025-03-12
00810051680003EyeBOXOculogica Inc.QEA2021-09-21