Taiwan FDA registration 30bfd1fdd8f667b02d860e4c39bd6efd

"Nationwide" Reston hearing aids (unsterilized)

TW: “全國” 力斯頓助聽器(未滅菌)

Taiwan·Risk Class 1·Sivantos GmbH;; SIVANTA PTE. LTD·Registered May 05, 2023 – May 05, 2028Active

Registration details

Analysis ID: 30bfd1fdd8f667b02d860e4c39bd6efd
Customs Code: DHA09402311007

Company information

Manufacturer: Sivantos GmbH;; SIVANTA PTE. LTD
Manufacturer Country: Germany;;Singapore
Authorized Representative: ALLDAY HEARING AID 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: 委託製造;; 輸入;; QMS/QSD

Dates and status

Registration Date: May 05, 2023
Expiry Date: May 05, 2028

About this record

Access comprehensive regulatory information for "Nationwide" Reston 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 30bfd1fdd8f667b02d860e4c39bd6efd and manufactured by Sivantos GmbH;; SIVANTA PTE. LTD. The authorized representative in Taiwan is ALLDAY HEARING AID CO., LTD..

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