Taiwan FDA registration 621b3c9b579e072057afaa4a2fc27615

"Brilliant Sound" hearing aids (unsterilized)

TW: "睿聲"助聽器(未滅菌)

Taiwan·Risk Class 1·STARKEY LABORATORIES, INC.·Registered May 29, 2019 – May 29, 2029Active

Registration details

Analysis ID: 621b3c9b579e072057afaa4a2fc27615
Customs Code: DHA09402049907

Company information

Manufacturer: STARKEY LABORATORIES, INC.
Manufacturer Country: United States
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: May 29, 2019
Expiry Date: May 29, 2029

About this record

Access comprehensive regulatory information for "Brilliant Sound" 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 621b3c9b579e072057afaa4a2fc27615 and manufactured by STARKEY LABORATORIES, INC.. The authorized representative in Taiwan is KING PAX TECHNOLOGY CO., LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.