Taiwan FDA registration 1d201539e71f3f88a534408aef74b057

"Berner Peak" air-guided hearing aids (unsterilized)

TW: "伯納峰" 氣導助聽器 (未滅菌)

Taiwan·Risk Class 1·DEMANT OPERATIONS POLAND SP. Z.O.O.;; SBO Hearing A/S·Registered May 11, 2016 – May 11, 2026Expired

Registration details

Analysis ID: 1d201539e71f3f88a534408aef74b057
Customs Code: DHA09401651503

Company information

Manufacturer: DEMANT OPERATIONS POLAND SP. Z.O.O.;; SBO Hearing A/S
Manufacturer Country: Poland;;Denmark
Authorized Representative: WiseLife CO., LTD.

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: Input;; Contract manufacturing

Dates and status

Registration Date: May 11, 2016
Expiry Date: May 11, 2026

About this record

Access comprehensive regulatory information for "Berner Peak" air-guided 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 1d201539e71f3f88a534408aef74b057 and manufactured by DEMANT OPERATIONS POLAND SP. Z.O.O.;; SBO Hearing A/S. The authorized representative in Taiwan is WiseLife CO., LTD..

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