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Certification
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Product name: Eye movement monitoring device, Monitor, eye movement
Model Name: M2S-ER
Classification No.: A28110.01
Classification Level: Class II
Item Definition: Measurement of eye movement. recording device
Certification date: April 4, 2022
Approval
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Certification standard: KSP ISO 13485:2016/ISO 13485:2016
Scope of certification: design, development and structure of eye movement monitoring device software
Certification date: June 20, 2022
FDA registration
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Registration number: 10061794.
Device Listing number: D362543,
D414762, D414763, D414764,
D414766, D414768
GMP
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Certificate of Conformity to Medical Device Manufacturing and Quality Control Standards (GMP)
Item Group: Software (Software as a Medical Device)
Certification date: October 13, 2022
Ministry of Food and Drug Safety Clinical trial
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[Authorized Institution Test Report]
[Clinical trial protocol]
[Clinical trial approval application]

SCI thesis

Nam HY, et al. Neurology, 2021, Pearls & Oysters: Labyrinthine infarction mimicking vestibular neuritis (IF: 11.8)
Kim KT, et al. J Neurol, 2021, Primary ventriculitis presenting with isolated vestibular syndrome (IF: 6.7)
Park YB, et al. J Neuroophthalmol, 2021, Bilateral internuclear ophthalmoplegia as a manifestation of varicella zoster encephalitis (IF: 4.4)
Kim KT, et al. J Neurol, 2021, Punctuate hippocampal lesions presenting with acute vestibular syndrome (IF: 6.7)
Kim JG, et al. J Neurol, 2022, Head‑impulse tests aid in differentiation of multiple system atrophy from Parkinson’s disease (IF: 6.7)
Kim KT, et al. Neurology, 2022, Clinical Reasoning: A 48-Year-Old Woman Presenting With Vertigo, Ptosis and Red Eyes (IF: 11.8)
Kim SH, et al. J Neuroophthalmol, 2022, Triquarter Visual Field Defect Due to Internal Carotid Artery Giant Aneurysm (IF: 4.4)
Hong JP, et al. J Neurol, 2022, Pseudo‑pupil sparing oculomotor nerve palsy in cavernous‑carotid fistula (IF: 6.7)
Kim JG, et al. Clin Aut Res, 2022, Utricular dysfunction in patients with orthostatic hypotension (IF: 5.6)
Kim HJ, et al. Ophthalmology, 2022, Isolated Inferior Rectus Palsy due to Oculomotor Dorsal Subnucleus Infarction (IF: 14.3)
Kim SH, et al. J Neurol, 2022, Alternating adduction hypertropia as a rare presentation of midbrain hemorrhage (IF: 6.7)
Lee SU, et al. J Neurol, 2022, Discordant horizontal–torsional nystagmus: a sign of posterior semicircular canal dysfunction (IF: 6.7)
Lee SU, et al. Front Neurol, 2022, Commentary: Is There an “Acquired Idiopathic Head-Shaking Nystagmus?”: A Discussion of
Mechanisms and Clinical Implications Based on a Case Report (IF: 4.1)
Lee SU, et al. J Neurol, 2022, Acute comitant strabismus in anti‑GQ1b antibody syndrome (IF 6.7)
Kong J, et al. J Clin Neurol, 2022, Isolated Bilateral Superior Cerebellar Peduncular Lesion Presenting Square-Wave Jerks and Ataxia (IF: 2.6)

Conference abstract

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XR technology

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2021 CES
Best of Innovation
It is recognized as the world's best product in health and wellness!
It is the only Korean startup to win the 2021 CES Best Innovation Award
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TEL : +82-2-508-0418 E-mail : m2s@m2skorea.com