Taiwan FDA registration b12e92d1d704aa59465f68b8d511f682

Dimensional device of "Oncos" heart valve complement (unsterilized)

TW: "昂可思" 心臟瓣膜彌補物之尺寸器 (未滅菌)

Taiwan·Risk Class 1·ON-X LIFE TECHNOLOGIES, INC.·Registered Jul 28, 2020 – Jul 28, 2025Expired

Registration details

Analysis ID: b12e92d1d704aa59465f68b8d511f682
Customs Code: DHA09402179401

Company information

Manufacturer: ON-X LIFE TECHNOLOGIES, INC.
Manufacturer Country: United States
Authorized Representative: EMERGO TAIWAN LIMITED

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: Jul 28, 2020
Expiry Date: Jul 28, 2025

About this record

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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