“HippoScreen” Stress EEG Assessment System - Taiwan Registration 25c03aaa6fa56fb240cd2df97b5f2a26
Access comprehensive regulatory information for “HippoScreen” Stress EEG Assessment System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 25c03aaa6fa56fb240cd2df97b5f2a26 and manufactured by Hongzhi Biomedical Technology Co., Ltd. The authorized representative in Taiwan is Hongzhi Biomedical Technology Co., Ltd.
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Device Details
Registration Details
25c03aaa6fa56fb240cd2df97b5f2a26
Ministry of Health Medical Device Manufacturing No. 008104
Product Details
The software medical device (SaMD) to assist in the diagnosis of suspected depression is used to analyze the time-domain and frequency-domain characteristics of the brainwave data measured by the brainwave smograph, and generate a quantitative index (SEA Index), which is provided to medical professionals as a diagnostic reference. This system is only used by medical professionals as a reference for clinical assistance in diagnosing suspected depression, and cannot replace the judgment of medical professionals.
K Neuroscience
K1400 brainwave scanner
Produced in Taiwan, China
Dates and Status
Oct 13, 2023
Oct 13, 2028