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Dimensional device of "Oncos" heart valve complement (unsterilized) - Taiwan Registration b12e92d1d704aa59465f68b8d511f682

Access comprehensive regulatory information for Dimensional device of "Oncos" 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 b12e92d1d704aa59465f68b8d511f682 and manufactured by ON-X LIFE TECHNOLOGIES, INC.. The authorized representative in Taiwan is EMERGO TAIWAN LIMITED.

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b12e92d1d704aa59465f68b8d511f682
Registration Details
Taiwan FDA Registration: b12e92d1d704aa59465f68b8d511f682
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Device Details

Dimensional device of "Oncos" heart valve complement (unsterilized)
TW: "ๆ˜‚ๅฏๆ€" ๅฟƒ่‡Ÿ็“ฃ่†œๅฝŒ่ฃœ็‰ฉไน‹ๅฐบๅฏธๅ™จ (ๆœชๆป…่Œ)
Risk Class 1

Registration Details

b12e92d1d704aa59465f68b8d511f682

DHA09402179401

Company Information

United States

Product Details

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.

E Cardiovascular Medicine Science

E.3945 Dimensioning apparatus for heart valves

Input;; QMS/QSD

Dates and Status

Jul 28, 2020

Jul 28, 2025