Taiwan FDA registration fd30aa62e290fb38a152613cfdd53d31

"Digibionic" Hearing Aid (Non-Sterile)

TW: "元健大和" 助聽器 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·MD·SIVANTOS PTE. LTD·Registered Dec 26, 2017 – Dec 26, 2027Active
Registration details
Analysis ID
fd30aa62e290fb38a152613cfdd53d31
License Form
Ministry of Health Medical Device Import No. 018657
Customs Code
DHA09401865707
Company information
Manufacturer
SIVANTOS PTE. LTD
Manufacturer Country
Singapore
Authorized Representative
DIGIBIONIC LIFESTYLE 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
Dec 26, 2017
Expiry Date
Dec 26, 2027
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About this record

Access comprehensive regulatory information for "Digibionic" 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 fd30aa62e290fb38a152613cfdd53d31 and manufactured by SIVANTOS PTE. LTD. The authorized representative in Taiwan is DIGIBIONIC LIFESTYLE CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including WSAUD A/S, SIVANTOS PTE LTD, and 2 recent registrations in the same category. 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.

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