Taiwan FDA registration c57b96216dc45c989113bf7cd887df55

"Creon" medical image storage device (unsterilized)

TW: “克里昂”醫學影像儲存裝置 (未滅菌)

Taiwan·Risk Class 1·SUNRISEMEDICAL CO., LTD.·Registered Apr 22, 2021 – Apr 22, 2026Expired

Registration details

Analysis ID: c57b96216dc45c989113bf7cd887df55

Company information

Manufacturer: SUNRISEMEDICAL CO., LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: OCTOREACH INTERNATIONAL INC.

Product details

Intended Use: Limited to the first level recognition range of the "Medical Image Storage Device (P.2010)" of the Measures for the Classification and Grading Management of Medical Devices.
Product Type (Level 1): P Radiology Science
Product Type (Level 2): P.2010 Medical image storage devices
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Apr 22, 2021
Expiry Date: Apr 22, 2026

About this record

Access comprehensive regulatory information for "Creon" medical image storage device (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number c57b96216dc45c989113bf7cd887df55 and manufactured by SUNRISEMEDICAL CO., LTD.. The authorized representative in Taiwan is OCTOREACH INTERNATIONAL INC..

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