Taiwan FDA registration 1a89a125d7449668a1c14783d5884c03
“Elixir” DESyne X2 Novolimus Eluting Coronary Stent System
TW: “依莉瑟”迪瑟第二代冠狀動脈塗藥支架系統
Taiwan·Risk Class 3·MD·Elixir Medical Corporation;;Acon Regulatory Consultancy Services Ltd·Registered Oct 10, 2018 – Oct 10, 2028ActiveRegistration details
- Analysis ID
- 1a89a125d7449668a1c14783d5884c03
- License Form
- Ministry of Health Medical Device Import No. 031833
- Customs Code
- DHA05603183300
Company information
- Manufacturer Country
- United States;;Ireland
- Authorized Representative
- CLOVERS BIOTECHNOLOGY CO., LTD.
Product details
- Intended Use
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- E Cardiovascular devices
- Product Type (Level 2)
- E0001 Cardiovascular stents
- Import Information
- Imported from abroad; Contract manufacturing
Dates and status
- Registration Date
- Oct 10, 2018
- Expiry Date
- Oct 10, 2028
About this record
Access comprehensive regulatory information for “Elixir” DESyne X2 Novolimus Eluting Coronary Stent System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 1a89a125d7449668a1c14783d5884c03 and manufactured by Elixir Medical Corporation;;Acon Regulatory Consultancy Services Ltd. The authorized representative in Taiwan is CLOVERS BIOTECHNOLOGY CO., LTD..
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