Taiwan FDA registration b9725aeb6516674da3da43323c5f1353
"Civanto" Odysphony hearing aids (unsterilized)
TW: "西萬拓" 奧德聲助聽器 (未滅菌)
Taiwan·Risk Class 1·SIVANTOS PTE LTD·Registered Jan 10, 2020 – Jan 10, 2030ActiveRegistration details
- Analysis ID
- b9725aeb6516674da3da43323c5f1353
- Customs Code
- DHA09402117601
Company information
- Manufacturer
- SIVANTOS PTE LTD
- Manufacturer Country
- Singapore
- Authorized Representative
- SONG JHU EN ENTERPRISE CO., LTD.
Product details
- Intended Use
- Limited to the first level recognition range of the classification and grading management measures for medical devices "hearing aids (G.3300)".
- Product Type (Level 1)
- G ENT Science
- Product Type (Level 2)
- G.3300 Hearing Aids
- Import Information
- import
Dates and status
- Registration Date
- Jan 10, 2020
- Expiry Date
- Jan 10, 2030
About this record
Access comprehensive regulatory information for "Civanto" Odysphony hearing aids (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b9725aeb6516674da3da43323c5f1353 and manufactured by SIVANTOS PTE LTD. The authorized representative in Taiwan is SONG JHU EN ENTERPRISE CO., 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.
Free DatabasePowered by Pure Global AI89,000+ Devices