Taiwan FDA registration ae8ba4e037ab19ac770eae4dddaa6d38

"Grace to the Lord" Danafort hearing aids (unsterilized)

TW: "頌主恩" 丹納福助聽器(未滅菌)

Taiwan·Risk Class 1·GN HEARING A/S;; GN RESOUND (MALAYSIA) SDN BHD·Registered Mar 15, 2023 – Mar 15, 2028Active

Registration details

Analysis ID: ae8ba4e037ab19ac770eae4dddaa6d38
Customs Code: DHA09402307301

Company information

Manufacturer: GN HEARING A/S;; GN RESOUND (MALAYSIA) SDN BHD
Manufacturer Country: Malaysia;;Denmark
Authorized Representative: SONG JHU EN ENTERPRISE 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: Mar 15, 2023
Expiry Date: Mar 15, 2028

About this record

Access comprehensive regulatory information for "Grace to the Lord" Danafort 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 ae8ba4e037ab19ac770eae4dddaa6d38 and manufactured by GN HEARING A/S;; GN RESOUND (MALAYSIA) SDN BHD. The authorized representative in Taiwan is SONG JHU EN ENTERPRISE CO., LTD..

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