Taiwan FDA registration 6c116ecdc6242fac8770c71b791002ce
"New Ear" Hearing aid (Non-Sterile)
TW: "新耳" 助聽器 (未滅菌)
Taiwan·Risk Class 1·MD·SIVANTOS PTE. LTD·Registered Oct 02, 2019 – Oct 02, 2024ExpiredRegistration details
- Analysis ID
- 6c116ecdc6242fac8770c71b791002ce
- License Form
- Ministry of Health Medical Device Import No. 020914
- Customs Code
- DHA09402091406
Company information
- Manufacturer
- SIVANTOS PTE. LTD
- Manufacturer Country
- Singapore
- Authorized Representative
- Faciox Inc.
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
- Oct 02, 2019
- Expiry Date
- Oct 02, 2024
About this record
Access comprehensive regulatory information for "New Ear" 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 6c116ecdc6242fac8770c71b791002ce and manufactured by SIVANTOS PTE. LTD. The authorized representative in Taiwan is Faciox Inc..
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