Taiwan FDA registration a2abc9860ce79203719e3422de559a62

"Gisse" Audiogram (Unsterilized)

TW: "吉斯艾" 聽力檢查計 (未滅菌)

Taiwan·Risk Class 1·DGS Diagnostics Sp. z o.o.;;DIAGNOSTIC GROUP LLC Doing Business As Grason-Stadler·Registered Mar 04, 2016 – Mar 04, 2026Expired

Registration details

Analysis ID: a2abc9860ce79203719e3422de559a62
Customs Code: DHA09401623102

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: Limited to the first level identification range of the "Audiogrammeter (G.1050)" of the Measures for the Classification and Grading Management of Medical Equipment.
Product Type (Level 1): G ENT Science
Product Type (Level 2): G.1050 Audiometer
Import Information: 輸入;; QMS/QSD;; 委託製造

Dates and status

Registration Date: Mar 04, 2016
Expiry Date: Mar 04, 2026

About this record

Access comprehensive regulatory information for "Gisse" Audiogram (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number a2abc9860ce79203719e3422de559a62 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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