Taiwan FDA registration f58f166847c82f43955ec750a41dc992

"Audita" audiometer (unsterilized) "Audia"

TW: "奧迪塔" 聽力檢查計 (未滅菌)“奧迪塔”

Taiwan·Risk Class 1·Auditdata A/S;;Inission Malmö AB·Registered May 03, 2023 – May 03, 2028Active

Registration details

Analysis ID: f58f166847c82f43955ec750a41dc992
Customs Code: DHA09402310603

Company information

Manufacturer: Auditdata A/S;;Inission Malmö AB
Manufacturer Country: Sweden;;Denmark
Authorized Representative: JEN SOUND ENTERPRISE CO., LTD.

Product details

Intended Use: Limited to the first level identification range of the "Audiogrammeter (G.1050)" of the Measures for the Classification and Grading Management of Medical Equipment.
Product Type (Level 1): G ENT Science
Product Type (Level 2): G.1050 Audiometer
Import Information: QMS/QSD;; 輸入;; 委託製造

Dates and status

Registration Date: May 03, 2023
Expiry Date: May 03, 2028

About this record

Access comprehensive regulatory information for "Audita" audiometer (unsterilized) "Audia" in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number f58f166847c82f43955ec750a41dc992 and manufactured by Auditdata A/S;;Inission Malmö AB. The authorized representative in Taiwan is JEN SOUND ENTERPRISE CO., LTD..

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