Taiwan FDA registration 3b909d645ff4d9811ab3afc92331da96
Edwards SAPIEN 3-Edwards Commander Kit
TW: 愛德華瑟皮恩三經導管心臟瓣膜及股動脈套管組
Taiwan·Risk Class 3·MD·Made (partial manufacturing process) in SINGAPORE;;EDWARDS LIFESCIENCES LLC·Registered Jul 27, 2017 – Jul 27, 2027ActiveRegistration details
- Analysis ID
- 3b909d645ff4d9811ab3afc92331da96
- License Form
- Ministry of Health Medical Device Import No. 029439
- Customs Code
- DHA05602943901
Company information
- Manufacturer Country
- United States;;Singapore
- Authorized Representative
- EDWARDS LIFESCIENCES (TAIWAN) CORPORATION
Product details
- Intended Use
- For details Chinese Performance changes of the approved copy of the imitation order and changes to the imitation order: For details, as Chinese the approved copy of the imitation order (the original approved copy of the imitation label on August 27, 107 was withdrawn and invalidated). Application for change items: imitation order and performance change: as detailed in Chinese copy of imitation order (the original copy of the imitation label approved copy on February 15, 109 is withdrawn and invalidated).
- Product Type (Level 1)
- E Cardiovascular devices
- Product Type (Level 2)
- E3925 Heart valve replacement
- Import Information
- Imports outside the borders;; Safety monitoring
Dates and status
- Registration Date
- Jul 27, 2017
- Expiry Date
- Jul 27, 2027
About this record
Access comprehensive regulatory information for Edwards SAPIEN 3-Edwards Commander Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 3b909d645ff4d9811ab3afc92331da96 and manufactured by Made (partial manufacturing process) in SINGAPORE;;EDWARDS LIFESCIENCES LLC. The authorized representative in Taiwan is EDWARDS LIFESCIENCES (TAIWAN) CORPORATION.
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