Taiwan FDA registration 11fe7d85fb486509c66b11b2be474188

"OSTAP" air-guided hearing aids (unsterilized)

TW: "歐仕達" 氣導式助聽器 (未滅菌)

Taiwan·Risk Class 1·AUSTAR HEARING SCIENCE&TECHNOLOGY (XIAMEN) CO., LTD.·Registered Mar 11, 2019 – Mar 11, 2024Expired

Registration details

Analysis ID: 11fe7d85fb486509c66b11b2be474188
Customs Code: DHA09600371302

Company information

Manufacturer: AUSTAR HEARING SCIENCE&TECHNOLOGY (XIAMEN) CO., LTD.
Manufacturer Country: China
Authorized Representative: MERRY FULING CO., LTD., TAIWAN BRANCH (SAMOA)

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;; Chinese goods

Dates and status

Registration Date: Mar 11, 2019
Expiry Date: Mar 11, 2024

About this record

Access comprehensive regulatory information for "OSTAP" air-guided 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 11fe7d85fb486509c66b11b2be474188 and manufactured by AUSTAR HEARING SCIENCE&TECHNOLOGY (XIAMEN) CO., LTD.. The authorized representative in Taiwan is MERRY FULING CO., LTD., TAIWAN BRANCH (SAMOA).

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