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Melody auditory brainstem implant - Taiwan Registration ea934ec6d119ccfa88207fc0d4149798

Access comprehensive regulatory information for Melody auditory brainstem implant in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number ea934ec6d119ccfa88207fc0d4149798 and manufactured by MED-EL Elektromedizinische Gerรคte GmbH. The authorized representative in Taiwan is QUALTECH CONSULTING CORPORATION.

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ea934ec6d119ccfa88207fc0d4149798
Registration Details
Taiwan FDA Registration: ea934ec6d119ccfa88207fc0d4149798
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Device Details

Melody auditory brainstem implant
TW: ็พŽๆจ‚่ฟช่ฝๆ€ง่…ฆๅนนๆคๅ…ฅ้ซ”
Risk Class 3

Registration Details

ea934ec6d119ccfa88207fc0d4149798

DHA05603097400

Company Information

Product Details

SYNCHRONY (PIN) ABI is indicated for patients 15 years of age and older with a diagnosis of NF2 and bilateral cochlear nerve dysfunction, or patients who are expected to lose function of the cochlear nerve due to tumor removal. Implantation of this device should be performed in conjunction with tumor removal surgery.

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Dates and Status

Apr 24, 2018

Apr 24, 2028