Taiwan FDA registration 2d8469276f2a92cf89dfbed2b0616d17

Hirombor Guided Listening Aid (Indestructible)

TW: 希萬博氣導式助聽器(未滅菌)

Taiwan·Risk Class 1·SIVANTOS PTE LTD·Registered Oct 04, 2023 – Oct 04, 2028Active

Registration details

Analysis ID: 2d8469276f2a92cf89dfbed2b0616d17
Customs Code: DHA09402326701

Company information

Manufacturer: SIVANTOS PTE LTD
Manufacturer Country: Singapore
Authorized Representative: GREAT TREE PHARMACY 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: QMS/QSD;; 輸入

Dates and status

Registration Date: Oct 04, 2023
Expiry Date: Oct 04, 2028

About this record

Access comprehensive regulatory information for Hirombor Guided Listening Aid (Indestructible) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 2d8469276f2a92cf89dfbed2b0616d17 and manufactured by SIVANTOS PTE LTD. The authorized representative in Taiwan is GREAT TREE PHARMACY CO., LTD..

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