Taiwan FDA registration 592701d9536e4e19b993b10489442287

“GSI” Audera Pro Clinical Evoked Potential and OAE System

TW: “吉斯艾”臨床誘發電位及耳聲傳射系統
Taiwan flagTaiwan·Risk Class 2·MD·DIAGNOSTIC GROUP LLC Doing Business As Grason-Stadler;;For use only by the Parts System Denda;;For spare parts system only·Registered Jul 09, 2021 – Jul 09, 2026Expired
Registration details
Analysis ID
592701d9536e4e19b993b10489442287
License Form
Ministry of Health Medical Device Import No. 034698
Customs Code
DHA05603469806
Company information
Manufacturer Country
United States;;Denmark
Authorized Representative
FORMOSA MEDICAL INSTRUMENTS CO., LTD.
Product details
Intended Use
Details are as detailed as approved Chinese instructions
Product Type (Level 1)
K Devices for neuroscience
Product Type (Level 2)
K1900 evokes a reactive acoustic stimulator
Import Information
Imported from abroad
Dates and status
Registration Date
Jul 09, 2021
Expiry Date
Jul 09, 2026
About this record

Access comprehensive regulatory information for “GSI” Audera Pro Clinical Evoked Potential and OAE System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 592701d9536e4e19b993b10489442287 and manufactured by DIAGNOSTIC GROUP LLC Doing Business As Grason-Stadler;;For use only by the Parts System Denda;;For spare parts system only. The authorized representative in Taiwan is FORMOSA MEDICAL INSTRUMENTS CO., LTD..

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