Taiwan FDA registration 16d4d9006da05cb007a966b027e6f2a1
Unified Auxiliary Equipment (Unsterilized)
TW: 統一 助聽器(未滅菌)
Taiwan·Risk Class 1·SIVANTOS PTE. LTD·Registered Oct 16, 2023 – Oct 16, 2028ActiveRegistration details
- Analysis ID
- 16d4d9006da05cb007a966b027e6f2a1
- Customs Code
- DHA09402327401
Company information
- Manufacturer
- SIVANTOS PTE. LTD
- Manufacturer Country
- Singapore
- Authorized Representative
- Unify the hearing aid line
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
- Oct 16, 2023
- Expiry Date
- Oct 16, 2028
About this record
Access comprehensive regulatory information for Unified Auxiliary Equipment (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 16d4d9006da05cb007a966b027e6f2a1 and manufactured by SIVANTOS PTE. LTD. The authorized representative in Taiwan is Unify the hearing aid line.
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