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"Audita" audiometer (unsterilized) "Audia" - Taiwan Registration f58f166847c82f43955ec750a41dc992

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 Malmรถ AB. The authorized representative in Taiwan is JEN SOUND ENTERPRISE CO., LTD..

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f58f166847c82f43955ec750a41dc992
Registration Details
Taiwan FDA Registration: f58f166847c82f43955ec750a41dc992
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Device Details

"Audita" audiometer (unsterilized) "Audia"
TW: "ๅฅง่ฟชๅก”" ่ฝๅŠ›ๆชขๆŸฅ่จˆ (ๆœชๆป…่Œ)โ€œๅฅง่ฟชๅก”โ€
Risk Class 1

Registration Details

f58f166847c82f43955ec750a41dc992

DHA09402310603

Company Information

Sweden;;Denmark

Product Details

Limited to the first level identification range of the "Audiogrammeter (G.1050)" of the Measures for the Classification and Grading Management of Medical Equipment.

G ENT Science

G.1050 Audiometer

QMS/QSD;; ่ผธๅ…ฅ;; ๅง”่จ—่ฃฝ้€ 

Dates and Status

May 03, 2023

May 03, 2028