Taiwan FDA registration afbba81f7bc6c02c1ade700cc0e85e85
"Eisengda" air-directed hearing aids (unsterilized)
TW: “叡聲達”氣導式助聽器(未滅菌)
Taiwan·Risk Class 1·GN HEARING A/S;; GN RESOUND (MALAYSIA) SDN BHD·Registered Apr 01, 2022 – Apr 01, 2027ActiveRegistration details
- Analysis ID
- afbba81f7bc6c02c1ade700cc0e85e85
- Customs Code
- DHA09402277502
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
- Apr 01, 2022
- Expiry Date
- Apr 01, 2027
About this record
Access comprehensive regulatory information for "Eisengda" 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 afbba81f7bc6c02c1ade700cc0e85e85 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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