Taiwan FDA registration 8dae7811c9b53528273e8e4b33c4f5be
"Qien" air-directed hearing aids (unsterilized)
TW: “奇恩” 氣導式助聽器(未滅菌)
Taiwan·Risk Class 1·GN HEARING A/S;; GN RESOUND (MALAYSIA) SDN BHD·Registered May 23, 2022 – May 23, 2027ActiveRegistration details
- Analysis ID
- 8dae7811c9b53528273e8e4b33c4f5be
- Customs Code
- DHA09402280804
Company information
- Manufacturer
- GN HEARING A/S;; GN RESOUND (MALAYSIA) SDN BHD
- Manufacturer Country
- Malaysia;;Denmark
- Authorized Representative
- Costco Wholesale Taiwan, Inc.
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
- May 23, 2022
- Expiry Date
- May 23, 2027
About this record
Access comprehensive regulatory information for "Qien" 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 8dae7811c9b53528273e8e4b33c4f5be and manufactured by GN HEARING A/S;; GN RESOUND (MALAYSIA) SDN BHD. The authorized representative in Taiwan is Costco Wholesale Taiwan, Inc..
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