Taiwan FDA registration b4a6c6c0d3ad85417fadb0a6553141e2

"Gisai" neonatal hearing screening instrument

TW: “吉斯艾”新生兒聽力篩檢儀

Taiwan·Risk Class 2·DGS Diagnostics Sp. z o.o.;;DIAGNOSTIC GROUP LLC Doing Business As Grason-Stadler·Registered Feb 29, 2020 – Mar 01, 2025Expired

Registration details

Analysis ID: b4a6c6c0d3ad85417fadb0a6553141e2
Customs Code: DHA05603337401

Company information

Manufacturer: DGS Diagnostics Sp. z o.o.;;DIAGNOSTIC GROUP LLC Doing Business As Grason-Stadler
Manufacturer Country: United States;;Poland
Authorized Representative: FORMOSA MEDICAL INSTRUMENTS CO., LTD.

Product details

Intended Use: For details, it is Chinese approved copy of the imitation order
Product Type (Level 1): K Neuroscience;; G Otolaryngology
Product Type (Level 2): G.1050 聽力檢查計;; K.1900 誘發反應聲刺激器
Import Information: import

Dates and status

Registration Date: Feb 29, 2020
Expiry Date: Mar 01, 2025

About this record

Access comprehensive regulatory information for "Gisai" neonatal hearing screening instrument in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b4a6c6c0d3ad85417fadb0a6553141e2 and manufactured by DGS Diagnostics Sp. z o.o.;;DIAGNOSTIC GROUP LLC Doing Business As Grason-Stadler. The authorized representative in Taiwan is FORMOSA MEDICAL INSTRUMENTS CO., LTD..

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