Taiwan FDA registration 600ce30d6388919e91c4e032ce064bc5

"Ednes" Aikman sound processor head element

TW: “艾德尼斯”艾克曼聲音處理器頭部元件

Taiwan·Risk Class 3·ADVANCED BIONICS, LLC·Registered Apr 14, 2022 – Apr 14, 2027Active

Registration details

Analysis ID: 600ce30d6388919e91c4e032ce064bc5
Customs Code: DHA05603537908

Company information

Manufacturer: ADVANCED BIONICS, LLC
Manufacturer Country: United States
Authorized Representative: I-LISTEN BIOTECHNOLOGICAL CO., LTD.

Product details

Intended Use: Details are as detailed as approved Chinese instructions
Product Type (Level 1): G ENT Science
Product Type (Level 2): G.0001 Artificial ear bug implanter
Import Information: Input;; The use of this device shall comply with the provisions of the Administrative Measures for the Implementation or Use of Medical Devices for Specific Medical Technology Inspection and Testing.

Dates and status

Registration Date: Apr 14, 2022
Expiry Date: Apr 14, 2027

About this record

Access comprehensive regulatory information for "Ednes" Aikman sound processor head element in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 600ce30d6388919e91c4e032ce064bc5 and manufactured by ADVANCED BIONICS, LLC. The authorized representative in Taiwan is I-LISTEN BIOTECHNOLOGICAL CO., LTD..

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