Taiwan FDA registration 900ccc3c0a4c8ad033c6c4af67ed4d0e

"Unitron" Hearing Aid (Non-Sterile)

TW: "優力康" 助聽器 (未滅菌)

Taiwan·Risk Class 1·MD·SONOVA HEARING (SUZHOU) CO. LTD.·Registered Mar 31, 2020 – Mar 31, 2025Expired

Registration details

Analysis ID: 900ccc3c0a4c8ad033c6c4af67ed4d0e
License Form: Ministry of Health Medical Device Land Transport No. 004126
Customs Code: DHA09600412605

Company information

Manufacturer: SONOVA HEARING (SUZHOU) CO. LTD.
Manufacturer Country: China
Authorized Representative: SONOVA TAIWAN PTE 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; Made in China

Dates and status

Registration Date: Mar 31, 2020
Expiry Date: Mar 31, 2025

About this record

Access comprehensive regulatory information for "Unitron" 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 900ccc3c0a4c8ad033c6c4af67ed4d0e and manufactured by SONOVA HEARING (SUZHOU) CO. LTD.. The authorized representative in Taiwan is SONOVA TAIWAN PTE 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.