Taiwan FDA registration 35a622468db235f26651c20960ea4fc4
MEDEL Bonebridge BCI System
TW: 美樂迪骨導式聽覺植入系統
Taiwan·Risk Class 3·MD·MED-EL Elektromedizinische Geräte GmbH·Registered Mar 16, 2015 – Mar 16, 2025ExpiredRegistration details
- Analysis ID
- 35a622468db235f26651c20960ea4fc4
- License Form
- Ministry of Health Medical Device Import No. 027138
- Customs Code
- DHA05602713803
Company information
- Manufacturer
- MED-EL Elektromedizinische Geräte GmbH
- Manufacturer Country
- Austria
- Authorized Representative
- MELODY MEDICAL INSTRUMENTS CORPORATION
Product details
- Intended Use
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- G ENT device
- Product Type (Level 2)
- G3300 hearing aid
- Import Information
- Imported from abroad; Contract manufacturing
Dates and status
- Registration Date
- Mar 16, 2015
- Expiry Date
- Mar 16, 2025
About this record
Access comprehensive regulatory information for MEDEL Bonebridge BCI System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 35a622468db235f26651c20960ea4fc4 and manufactured by MED-EL Elektromedizinische Geräte GmbH. The authorized representative in Taiwan is MELODY MEDICAL INSTRUMENTS CORPORATION.
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