Taiwan FDA registration ea934ec6d119ccfa88207fc0d4149798

Melody auditory brainstem implant

TW: 美樂迪聽性腦幹植入體

Taiwan·Risk Class 3·MED-EL Elektromedizinische Geräte GmbH·Registered Apr 24, 2018 – Apr 24, 2028Active

Registration details

Analysis ID: ea934ec6d119ccfa88207fc0d4149798
Customs Code: DHA05603097400

Company information

Manufacturer: MED-EL Elektromedizinische Geräte GmbH
Manufacturer Country: Austria
Authorized Representative: QUALTECH CONSULTING CORPORATION

Product details

Intended Use: 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.
Product Type (Level 1): G ENT Science
Product Type (Level 2): G.0001 Artificial ear bug implanter
Import Information: Safety monitoring;; import

Dates and status

Registration Date: Apr 24, 2018
Expiry Date: Apr 24, 2028

About this record

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 Geräte GmbH. The authorized representative in Taiwan is QUALTECH CONSULTING CORPORATION.

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