Taiwan FDA registration 2f050687adf05642a9a1847e5a656454

"Neders" audiometer (unsterilized)

TW: "耐德斯"聽力檢查計(未滅菌)

Taiwan·Risk Class 1·Natus Medical Denmark ApS;; Natus Manufacturing Limited·Registered Apr 20, 2023 – Apr 20, 2028Active

Registration details

Analysis ID: 2f050687adf05642a9a1847e5a656454
Customs Code: DHA09402309307

Company information

Manufacturer: Natus Medical Denmark ApS;; Natus Manufacturing Limited
Manufacturer Country: Ireland;;Denmark
Authorized Representative: Access-2-Healthcare 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

Dates and status

Registration Date: Apr 20, 2023
Expiry Date: Apr 20, 2028

About this record

Access comprehensive regulatory information for "Neders" audiometer (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 2f050687adf05642a9a1847e5a656454 and manufactured by Natus Medical Denmark ApS;; Natus Manufacturing Limited. The authorized representative in Taiwan is Access-2-Healthcare CO., LTD..

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