Taiwan FDA registration 91923ffea628e31e7af9ec2dff48a76e

"Longyin" air-directed hearing aids (unsterilized)

TW: “龍音” 氣導式助聽器 (未滅菌)

Taiwan·Risk Class 1·AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.·Registered Mar 08, 2022 – Mar 08, 2027Active

Registration details

Analysis ID: 91923ffea628e31e7af9ec2dff48a76e
Customs Code: DHA09600460902

Company information

Manufacturer: AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.
Manufacturer Country: China
Authorized Representative: Longyin Industrial 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;; Chinese goods;; input

Dates and status

Registration Date: Mar 08, 2022
Expiry Date: Mar 08, 2027

About this record

Access comprehensive regulatory information for "Longyin" 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 91923ffea628e31e7af9ec2dff48a76e and manufactured by AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD.. The authorized representative in Taiwan is Longyin Industrial 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.