Taiwan FDA registration 18da781edeb21c3f7176dae571ee604a

"JEN SOUND" Air conduction Hearing Aid (Non-Sterile)

TW: "建聲" 氣導式助聽器 (未滅菌)

Taiwan·Risk Class 1·MD·Sonova Operations Center Vietnam Co., Ltd·Registered Aug 03, 2020 – Aug 03, 2025Expired

Registration details

Analysis ID: 18da781edeb21c3f7176dae571ee604a
License Form: Ministry of Health Medical Device Import No. 021815
Customs Code: DHA09402181509

Company information

Manufacturer: Sonova Operations Center Vietnam Co., Ltd
Manufacturer Country: Viet Nam
Authorized Representative: JEN SOUND 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: Aug 03, 2020
Expiry Date: Aug 03, 2025

About this record

Access comprehensive regulatory information for "JEN SOUND" Air conduction Hearing Aid (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 18da781edeb21c3f7176dae571ee604a and manufactured by Sonova Operations Center Vietnam Co., Ltd. The authorized representative in Taiwan is JEN SOUND ENTERPRISE CO., LTD..

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