Taiwan FDA registration a18e441bc6b24bb6aca15e4d0b94e122

"Hearton" NuEar Air Conduction Hearing Aids (Non-Sterile)

TW: "佳聲" 紐伊兒助聽器 (未滅菌)

Taiwan·Risk Class 1·MD·STARKEY HEARING TECHNOLOGIES·Registered Mar 31, 2016 – Mar 31, 2021Expired

Registration details

Analysis ID: a18e441bc6b24bb6aca15e4d0b94e122
License Form: Ministry of Health Medical Device Import No. 016350
Customs Code: DHA09401635000

Company information

Manufacturer: STARKEY HEARING TECHNOLOGIES
Manufacturer Country: United States
Authorized Representative: HEARTON ENTERPRISE CO., LTD.

Product details

Intended Use: Limited to the first level identification range of the Measures for the Administration of Medical Devices "Hearing Aids (G.3300)".
Product Type (Level 1): G ENT device
Product Type (Level 2): G3300 hearing aid
Import Information: Imported from abroad

Dates and status

Registration Date: Mar 31, 2016
Expiry Date: Mar 31, 2021

About this record

Access comprehensive regulatory information for "Hearton" NuEar Air Conduction Hearing Aids (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number a18e441bc6b24bb6aca15e4d0b94e122 and manufactured by STARKEY HEARING TECHNOLOGIES. The authorized representative in Taiwan is HEARTON ENTERPRISE CO., LTD..

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