Taiwan FDA registration a2f5a40a117927fe94d409577b13e1f7
"Quiet" air-directed hearing aids (unsterilized)
TW: “靜好” 氣導式助聽器(未滅菌)
Taiwan·Risk Class 1·GN HEARING A/S;; GN RESOUND (MALAYSIA) SDN BHD·Registered Aug 01, 2023 – Aug 01, 2028ActiveRegistration details
- Analysis ID
- a2f5a40a117927fe94d409577b13e1f7
- Customs Code
- DHA09402319301
Company information
- Manufacturer
- GN HEARING A/S;; GN RESOUND (MALAYSIA) SDN BHD
- Manufacturer Country
- Malaysia;;Denmark
- Authorized Representative
- Jinghao Technology 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
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Aug 01, 2023
- Expiry Date
- Aug 01, 2028
About this record
Access comprehensive regulatory information for "Quiet" air-directed 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 a2f5a40a117927fe94d409577b13e1f7 and manufactured by GN HEARING A/S;; GN RESOUND (MALAYSIA) SDN BHD. The authorized representative in Taiwan is Jinghao Technology Co., Ltd.
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