Taiwan FDA registration d0175a8845aa427fbc2718ef91f685ff

Sizer of "Edward" heart valve complement (unsterilized)

TW: “愛德華”心臟瓣膜彌補物之尺寸器 (未滅菌)

Taiwan·Risk Class 1·EDWARDS LIFESCIENCES LLC·Registered Sep 24, 2010 – Sep 24, 2025Expired

Registration details

Analysis ID: d0175a8845aa427fbc2718ef91f685ff
Customs Code: DHA04400924605

Company information

Manufacturer: EDWARDS LIFESCIENCES LLC
Manufacturer Country: United States
Authorized Representative: EDWARDS LIFESCIENCES (TAIWAN) CORPORATION

Product details

Intended Use: It is limited to the first level of identification scope of the Dimension Device (E.3945) of the Classification and Grading Management Measures for Medical Devices.
Product Type (Level 1): E Cardiovascular Medicine Science
Product Type (Level 2): E.3945 Dimensioning apparatus for heart valves
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Sep 24, 2010
Expiry Date: Sep 24, 2025

About this record

Access comprehensive regulatory information for Sizer of "Edward" heart valve complement (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number d0175a8845aa427fbc2718ef91f685ff and manufactured by EDWARDS LIFESCIENCES LLC. The authorized representative in Taiwan is EDWARDS LIFESCIENCES (TAIWAN) CORPORATION.

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