Taiwan FDA registration 3bc94fa05cc59573b6b9617aa974fb99

Philips hearing aids (unsterilized)

TW: “飛利浦”助聽器(未滅菌)

Taiwan·Risk Class 1·DEMANT OPERATIONS POLAND SP. Z.O.O.;; SBO Hearing A/S·Registered May 28, 2019 – May 28, 2029Active

Registration details

Analysis ID: 3bc94fa05cc59573b6b9617aa974fb99
Customs Code: DHA09402049703

Company information

Manufacturer: DEMANT OPERATIONS POLAND SP. Z.O.O.;; SBO Hearing A/S
Manufacturer Country: Poland;;Denmark
Authorized Representative: BAY AUDIOLOGY (TAIWAN) LIMITED

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: QMS/QSD;; 輸入;; 委託製造

Dates and status

Registration Date: May 28, 2019
Expiry Date: May 28, 2029

About this record

Access comprehensive regulatory information for Philips 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 3bc94fa05cc59573b6b9617aa974fb99 and manufactured by DEMANT OPERATIONS POLAND SP. Z.O.O.;; SBO Hearing A/S. The authorized representative in Taiwan is BAY AUDIOLOGY (TAIWAN) LIMITED.

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