Taiwan FDA registration dc005790bd42c0236a2d2a8fa38ac8a8

"Rhyme" air-directed hearing aids (unsterilized)

TW: “上韻”氣導式助聽器(未滅菌)

Taiwan·Risk Class 1·SIVANTOS PTE LTD·Registered Sep 14, 2021 – Sep 14, 2026Active

Registration details

Analysis ID: dc005790bd42c0236a2d2a8fa38ac8a8
Customs Code: DHA09402265008

Company information

Manufacturer: SIVANTOS PTE LTD
Manufacturer Country: Singapore
Authorized Representative: Shangyun Instrument 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: Sep 14, 2021
Expiry Date: Sep 14, 2026

About this record

Access comprehensive regulatory information for "Rhyme" air-directed 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 dc005790bd42c0236a2d2a8fa38ac8a8 and manufactured by SIVANTOS PTE LTD. The authorized representative in Taiwan is Shangyun Instrument CO., LTD..

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