EMDAS Eye Movement Detection and Analysis System (Jasmines EM-2000B-D01)
EMDAS System (Eye Movement Diagnostic Analysis)Featured

EMDAS Eye Movement Detection and Analysis System (Jasmines EM-2000B-D01)

Manufacturer Brand: Jasmines

EMDAS (Eye Movement Detection and Analysis System) is a brain function test system that uses eye movement and saccade parameters, objective behavioral indicators of brain function, for early screening and auxiliary diagnosis of Mild Cognitive Impairment (MCI), a transitional state toward Alzheimer's disease and other dementias. A clinical study (Gerontology, 2022) found saccade task performance correlated significantly with MMSE and MoCA scores and declined with increasing severity of cognitive impairment. NMPA (China) medical device approval was obtained in December 2023.

Category
EMDAS System (Eye Movement Diagnostic Analysis)
Info & pricing
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Medical Device Distribution License (Thai FDA)ISO 13485 CertificationISO 9001 Certification

Regulatory Note

Intended as a screening and auxiliary diagnostic aid to support clinical judgement, not a replacement for a physician's diagnosis.

Medical device registration (Thai FDA)

Medical device import notification under the Medical Device Act B.E. 2551 (2008)

Notified to Thai FDA
Notification no.
68-2-2-2-0011913
Notification holder (importer)
Lord Mind Technology (Thailand) Co., Ltd. (establishment reg. กท. สน. 589/2564)
Issued
11 November 2025
Valid until
31 December 2029
Manufacturer
Chengdu Jasmines BioTech INC (Chengdu, Sichuan, China)
Covered models
EM-2000C-D01 (Brain physiology and cognitive function assisted evaluation system, EM-2000C series)
Intended use
Assists in the assessment of brain physiology and cognitive function, and assists physicians in the diagnosis of mild cognitive impairment (MCI).

Light hazard test report

ISO 15004-2:2024 (Light hazard protection) — Classified as a Group 1 instrument — pass

Hangzhou EVERFINE Test and Calibration Technology Co., Ltd. · Report no. N20260915951003 · 9 October 2026

Summarised from documents issued by the Thai Food and Drug Administration. Please verify the latest status with the Thai FDA or contact our team.

Specifications

  • Clinically validated accuracy: 85% (manufacturer data)
  • Test time: Early screening 5 min / auxiliary diagnosis 15 min
  • Clinical trials: 400 GCP clinical trial cases
  • Average accuracy: Minimum 0.1°, typical 0°–0.7°
  • Spatial resolution: ≤0.025°
  • Tracking angle: Horizontal ±30°, vertical ±20°
  • Exploratory eye movement parameters related to neuropsychological assessments (MMSE and MoCA)
  • High performance, simple operation, anti-interference
  • Includes analysis software and an AI-assisted diagnosis report
  • Approval: NMPA (China) medical device approval (December 2023)

Clinical Applications

  • Early screening and auxiliary diagnosis of Mild Cognitive Impairment (MCI)
  • Brain function and cognitive assessment in the elderly alongside MMSE and MoCA

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This is preliminary information for presentation purposes. Please contact our team for current specifications and certification documents.

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