Taiwan FDA registration 12853e026c2bf694fefa2bae0aff0488

"Melody" acoustic and electrical stimulation sound processor

TW: “美樂迪”聲電刺激聲音處理器

Taiwan·Risk Class 3·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Registered Jun 24, 2010 – Jun 24, 2015Cancelled

Registration details

Analysis ID: 12853e026c2bf694fefa2bae0aff0488
Customs Code: DHA00602122501

Company information

Manufacturer: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
Manufacturer Country: Austria
Authorized Representative: MELODY MEDICAL INSTRUMENTS CORPORATION

Product details

Intended Use: The DUET2 sound processor is suitable for MED-EL ear system users aged 12 years and older with low-frequency hearing, ranging from 125 Hz to 1500 Hz and hearing loss between 30 dBHL and 80 dBHL. The DUET2 sound processor is part of the MED-EL electronic ear system, and the indications of the original MED-EL artificial ear are also indications for this product.
Product Type (Level 1): G ENT Science
Import Information: import

Dates and status

Registration Date: Jun 24, 2010
Expiry Date: Jun 24, 2015
Cancellation Date: May 28, 2018

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "Melody" acoustic and electrical stimulation sound processor in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 12853e026c2bf694fefa2bae0aff0488 and manufactured by MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH. The authorized representative in Taiwan is MELODY MEDICAL INSTRUMENTS CORPORATION.

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