Edwards SAPIEN 3-Edwards Commander Kit - Taiwan Registration 3b909d645ff4d9811ab3afc92331da96
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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Device Details
Registration Details
3b909d645ff4d9811ab3afc92331da96
Ministry of Health Medical Device Import No. 029439
DHA05602943901
Product Details
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the approved copy of the imitation order (the original approved copy of the imitation label on August 27, 107 was withdrawn and invalidated).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in Chinese copy of imitation order (the original copy of the imitation label approved copy on February 15, 109 is withdrawn and invalidated).
E Cardiovascular devices
E3925 Heart valve replacement
Imports outside the borders;; Safety monitoring
Dates and Status
Jul 27, 2017
Jul 27, 2027