Taiwan FDA registration 09b5654d0a85cc2787558150f7b4fbd7
"Eliser" Denex coronary artery coating stent system
TW: “依莉瑟”迪耐克斯冠狀動脈塗藥支架系統
Taiwan·Risk Class 3·Acorn Regulatory Consultancy Services Ltd;; Elixir Medical Corporation·Registered Mar 26, 2022 – Mar 26, 2027ActiveRegistration details
- Analysis ID
- 09b5654d0a85cc2787558150f7b4fbd7
- Customs Code
- DHA05603534007
Company information
- Manufacturer Country
- Ireland;;United States
- Authorized Representative
- WONDERVILLE 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)
- E.0001 Cardiovascular stents
- Import Information
- Input;; Security Surveillance;; Contract manufacturing
Dates and status
- Registration Date
- Mar 26, 2022
- Expiry Date
- Mar 26, 2027
About this record
Access comprehensive regulatory information for "Eliser" Denex coronary artery coating 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 09b5654d0a85cc2787558150f7b4fbd7 and manufactured by Acorn Regulatory Consultancy Services Ltd;; Elixir Medical Corporation. The authorized representative in Taiwan is WONDERVILLE CO., LTD..
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