Taiwan FDA registration 9900c549abc102e6f5433e6ce451fc1b

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

TW: "柏納峰"氣導式助聽器 (未滅菌)

Taiwan·Risk Class 1·DEMANT OPERATIONS POLAND SP. Z.O.O.;; SBO Hearing A/S·Registered Apr 08, 2015 – Apr 08, 2025Expired

Registration details

Analysis ID: 9900c549abc102e6f5433e6ce451fc1b
Customs Code: DHA09401508104

Company information

Manufacturer: DEMANT OPERATIONS POLAND SP. Z.O.O.;; SBO Hearing A/S
Manufacturer Country: Poland;;Denmark
Authorized Representative: HEARINGAID. ASIA 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: 輸入;; QMS/QSD;; 委託製造

Dates and status

Registration Date: Apr 08, 2015
Expiry Date: Apr 08, 2025

About this record

Access comprehensive regulatory information for "Bona 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 9900c549abc102e6f5433e6ce451fc1b and manufactured by DEMANT OPERATIONS POLAND SP. Z.O.O.;; SBO Hearing A/S. The authorized representative in Taiwan is HEARINGAID. ASIA CO., LTD..

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