Taiwan FDA registration eb0580df0d0791d3953ce1d4dda7cac1
"Riston" hearing aids (unsterilized)
TW: "瑞斯敦" 助聽器 (未滅菌)
Taiwan·Risk Class 1·SIVANTOS PTE. LTD·Registered Jun 28, 2019 – Jun 28, 2029ActiveRegistration details
- Analysis ID
- eb0580df0d0791d3953ce1d4dda7cac1
- Customs Code
- DHA09402059901
Company information
- Manufacturer
- SIVANTOS PTE. LTD
- Manufacturer Country
- Singapore
- Authorized Representative
- BAY AUDIOLOGY (TAIWAN) LIMITED
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
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Jun 28, 2019
- Expiry Date
- Jun 28, 2029
About this record
Access comprehensive regulatory information for "Riston" 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 eb0580df0d0791d3953ce1d4dda7cac1 and manufactured by SIVANTOS PTE. LTD. The authorized representative in Taiwan is BAY AUDIOLOGY (TAIWAN) LIMITED.
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