Taiwan FDA registration 4a1bdab1c93a8e99dddd6bf9ea4edde6

"Fruit" vertebral body dilation balloon catheter (unsterilized)

TW: “碩果”椎體擴張球囊導管(未滅菌)

Taiwan·Risk Class 2·Shuoguo Biomedical Technology Co., Ltd.; Jiangsu Changmei Medtech Co., Ltd.·Registered Mar 30, 2023 – Mar 30, 2028Active

Registration details

Analysis ID: 4a1bdab1c93a8e99dddd6bf9ea4edde6
Customs Code: DHA09200146608

Company information

Manufacturer: Shuoguo Biomedical Technology Co., Ltd.; Jiangsu Changmei Medtech Co., Ltd.
Manufacturer Country: Taiwan, Province of China;;China
Authorized Representative: SOCKO MEDICAL CO., LTD.

Product details

Intended Use: Details are as detailed as approved Chinese instructions
Product Type (Level 1): N Orthopedics
Product Type (Level 2): N.9999 Miscellaneous
Import Information: Chinese goods;; Input;; Contract manufacturing

Dates and status

Registration Date: Mar 30, 2023
Expiry Date: Mar 30, 2028

About this record

Access comprehensive regulatory information for "Fruit" vertebral body dilation balloon catheter (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4a1bdab1c93a8e99dddd6bf9ea4edde6 and manufactured by Shuoguo Biomedical Technology Co., Ltd.; Jiangsu Changmei Medtech Co., Ltd.. The authorized representative in Taiwan is SOCKO MEDICAL CO., LTD..

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