Taiwan FDA registration 25c03aaa6fa56fb240cd2df97b5f2a26
“HippoScreen” Stress EEG Assessment System
TW: “宏智生醫”憂可視腦波壓力評估系統
Taiwan·Risk Class 2·MD·Hongzhi Biomedical Technology Co., Ltd·Registered Oct 13, 2023 – Oct 13, 2028ActiveRegistration details
- Analysis ID
- 25c03aaa6fa56fb240cd2df97b5f2a26
- License Form
- Ministry of Health Medical Device Manufacturing No. 008104
Company information
- Manufacturer
- Hongzhi Biomedical Technology Co., Ltd
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Hongzhi Biomedical Technology Co., Ltd
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- K Neuroscience
- Product Type (Level 2)
- K1400 brainwave scanner
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Oct 13, 2023
- Expiry Date
- Oct 13, 2028
About this record
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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