Taiwan FDA registration b00a75e3c47977161b778bdbe3eab393
MED-EL Mi1200 SYNCHRONY ABI
TW: 美樂迪聽性腦幹植入體
Taiwan·Risk Class 3·MD·MED-EL Elektromedizinische Geräte GmbH·Registered Apr 24, 2018 – Apr 24, 2028ActiveRegistration details
- Analysis ID
- b00a75e3c47977161b778bdbe3eab393
- License Form
- Ministry of Health Medical Device Import No. 030974
- Customs Code
- DHA05603097400
Company information
- Manufacturer
- MED-EL Elektromedizinische Geräte GmbH
- Manufacturer Country
- Austria
- Authorized Representative
- MELODY MEDICAL INSTRUMENTS 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 device
- Product Type (Level 2)
- G0001 Cochlear implant
- Import Information
- Imports outside the borders;; Safety monitoring
Dates and status
- Registration Date
- Apr 24, 2018
- Expiry Date
- Apr 24, 2028
About this record
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 Geräte GmbH. The authorized representative in Taiwan is MELODY MEDICAL INSTRUMENTS CORPORATION.
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