Taiwan FDA registration ff5ecc6613b72eaa8871e0d607bca591
“Elixir”DynamX Novolimus Eluting Coronary Bioadaptor System
TW: “依莉瑟”迪耐克斯冠狀動脈塗藥支架系統
Taiwan·Risk Class 3·MD·Elixir Medical Corporation;;Acon Regulatory Consultancy Services Ltd·Registered Mar 26, 2022 – Mar 26, 2027ActiveRegistration details
- Analysis ID
- ff5ecc6613b72eaa8871e0d607bca591
- License Form
- Ministry of Health Medical Device Import No. 035340
- Customs Code
- DHA05603534007
Company information
- Manufacturer Country
- United States;;Ireland
- Authorized Representative
- CLOVERS BIOTECHNOLOGY CO., LTD.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- E Cardiovascular Medicine Science
- Product Type (Level 2)
- E0001 Cardiovascular stents
- Import Information
- Imported from abroad; Contract manufacturing;; Security monitoring
Dates and status
- Registration Date
- Mar 26, 2022
- Expiry Date
- Mar 26, 2027
About this record
Access comprehensive regulatory information for “Elixir”DynamX Novolimus Eluting Coronary Bioadaptor System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number ff5ecc6613b72eaa8871e0d607bca591 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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