Taiwan FDA registration 5a146d5d4055eb849f4e2879b07ec9a3
"New Care" Hearing Aids (Non-Sterile)
TW: "富聆" 助聽器 (未滅菌)
Taiwan·Risk Class 1·MD·SIVANTOS PTE. LTD·Registered Dec 15, 2017 – Dec 15, 2027ActiveRegistration details
- Analysis ID
- 5a146d5d4055eb849f4e2879b07ec9a3
- License Form
- Ministry of Health Medical Device Import No. 018614
- Customs Code
- DHA09401861402
Company information
- Manufacturer
- SIVANTOS PTE. LTD
- Manufacturer Country
- Singapore
- Authorized Representative
- MERRY FULING CO., LTD., TAIWAN BRANCH (SAMOA)
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 15, 2017
- Expiry Date
- Dec 15, 2027
About this record
Access comprehensive regulatory information for "New Care" 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 5a146d5d4055eb849f4e2879b07ec9a3 and manufactured by SIVANTOS PTE. LTD. The authorized representative in Taiwan is MERRY FULING CO., LTD., TAIWAN BRANCH (SAMOA).
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.
Free DatabasePowered by Pure Global AI89,000+ Devices