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"Melody" acoustic and electrical stimulation sound processor - Taiwan Registration 12853e026c2bf694fefa2bae0aff0488

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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12853e026c2bf694fefa2bae0aff0488
Registration Details
Taiwan FDA Registration: 12853e026c2bf694fefa2bae0aff0488
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Device Details

"Melody" acoustic and electrical stimulation sound processor
TW: โ€œ็พŽๆจ‚่ฟชโ€่ฒ้›ปๅˆบๆฟ€่ฒ้Ÿณ่™•็†ๅ™จ
Risk Class 3
Cancelled

Registration Details

12853e026c2bf694fefa2bae0aff0488

DHA00602122501

Company Information

Product Details

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.

G ENT Science

import

Dates and Status

Jun 24, 2010

Jun 24, 2015

May 28, 2018

Cancellation Information

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