Taiwan FDA registration 5976ecc1aaf9e156359f4e746d25ada6

"Intetong" hearing aids (unsterilized)

TW: "音特通"助聽器(未滅菌)

Taiwan·Risk Class 1·GN HEARING A/S;; GN RESOUND (MALAYSIA) SDN BHD·Registered Apr 09, 2019 – Apr 09, 2029Active

Registration details

Analysis ID: 5976ecc1aaf9e156359f4e746d25ada6
Customs Code: DHA09402028208

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: Input;; QMS/QSD

Dates and status

Registration Date: Apr 09, 2019
Expiry Date: Apr 09, 2029

About this record

Access comprehensive regulatory information for "Intetong" 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 5976ecc1aaf9e156359f4e746d25ada6 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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