MED-EL Mi1200 SYNCHRONY ABI - Taiwan Registration b00a75e3c47977161b778bdbe3eab393
Access comprehensive regulatory information for MED-EL Mi1200 SYNCHRONY ABI in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number b00a75e3c47977161b778bdbe3eab393 and manufactured by MED-EL Elektromedizinische Gerรคte GmbH. The authorized representative in Taiwan is MELODY MEDICAL INSTRUMENTS CORPORATION.
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Device Details
Registration Details
b00a75e3c47977161b778bdbe3eab393
Ministry of Health Medical Device Import No. 030974
DHA05603097400
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.
G ENT device
G0001 Cochlear implant
Imports outside the borders;; Safety monitoring
Dates and Status
Apr 24, 2018
Apr 24, 2028