Taiwan FDA registration 657896d65b2284d8ee9e91030d07ba50

Edward Serpien III and Serpien III Superior Transcatheter Heart Valve Hood Group.

TW: 愛德華瑟皮恩三和瑟皮恩三優創經導管心臟瓣膜套管組。
Taiwan flagTaiwan·Risk Class 3·EDWARDS LIFESCIENCES LLC;; Made (部分製程) in SINGAPORE·Registered Jul 27, 2017 – Jul 27, 2027Active
Registration details
Analysis ID
657896d65b2284d8ee9e91030d07ba50
Customs Code
DHA05602943901
Company information
Manufacturer Country
United States;;Singapore
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the approved copy of the imitation order (the original approved copy of the imitation label on August 27, 107 was withdrawn and invalidated).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in Chinese copy of imitation order (the original copy of the imitation label approved copy on February 15, 109 is withdrawn and invalidated).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 Medicine Science
Product Type (Level 2)
E.3925 Hypocardial membrane substitutions
Import Information
Import;; Safety monitoring
Dates and status
Registration Date
Jul 27, 2017
Expiry Date
Jul 27, 2027
About this record

Access comprehensive regulatory information for Edward Serpien III and Serpien III Superior Transcatheter Heart Valve Hood Group. in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 657896d65b2284d8ee9e91030d07ba50 and manufactured by EDWARDS LIFESCIENCES LLC;; Made (部分製程) in SINGAPORE. The authorized representative in Taiwan is EDWARDS LIFESCIENCES (TAIWAN) CORPORATION.

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