Taiwan FDA registration f1b80e59f6be859b06f1c2cb3ae082d6

"SoundStar" hearing aids (unsterilized)

TW: "銳聲達" 助聽器 (未滅菌)

Taiwan·Risk Class 1·GN HEARING A/S;; GN RESOUND (MALAYSIA) SDN BHD·Registered Sep 18, 2017 – Sep 18, 2027Active

Registration details

Analysis ID: f1b80e59f6be859b06f1c2cb3ae082d6
Customs Code: DHA09401832001

Company information

Manufacturer: GN HEARING A/S;; GN RESOUND (MALAYSIA) SDN BHD
Manufacturer Country: Malaysia;;Denmark
Authorized Representative: KING PAX TECHNOLOGY CO., LTD.

Product details

Intended Use: Limited to the first level recognition range of the classification and grading management measures for medical devices "hearing aids (G.3300)".
Product Type (Level 1): G ENT Science
Product Type (Level 2): G.3300 Hearing Aids
Import Information: import

Dates and status

Registration Date: Sep 18, 2017
Expiry Date: Sep 18, 2027

About this record

Access comprehensive regulatory information for "SoundStar" hearing aids (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number f1b80e59f6be859b06f1c2cb3ae082d6 and manufactured by GN HEARING A/S;; GN RESOUND (MALAYSIA) SDN BHD. The authorized representative in Taiwan is KING PAX TECHNOLOGY CO., LTD..

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