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Edward Serpien III and Serpien III Superior Transcatheter Heart Valve Hood Group. - Taiwan Registration 657896d65b2284d8ee9e91030d07ba50

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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657896d65b2284d8ee9e91030d07ba50
Registration Details
Taiwan FDA Registration: 657896d65b2284d8ee9e91030d07ba50
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Device Details

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。
Risk Class 3

Registration Details

657896d65b2284d8ee9e91030d07ba50

DHA05602943901

Company Information

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the approved copy of the imitation order (the original approved copy of the imitation label on August 27, 107 was withdrawn and invalidated).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in Chinese copy of imitation order (the original copy of the imitation label approved copy on February 15, 109 is withdrawn and invalidated).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 Medicine Science

E.3925 Hypocardial membrane substitutions

Import;; Safety monitoring

Dates and Status

Jul 27, 2017

Jul 27, 2027