Taiwan FDA registration 74b7ce7fc3c3864a25d20a7adb9d5878

"Bersen" non-compliant coronary balloon catheter

TW: “百爾森” 非順應性冠狀動脈球囊導管
Taiwan flagTaiwan·Risk Class 2·BIOSENSORS EUROPE SA;; BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTD.·Registered Mar 19, 2021 – Mar 19, 2026Expired
Registration details
Analysis ID
74b7ce7fc3c3864a25d20a7adb9d5878
Customs Code
DHA05603446509
Company information
Manufacturer Country
Switzerland;;Singapore
Authorized Representative
K&C MEDICAL CO., LTD.
Product details
Intended Use
For details, it is Chinese approved copy of the imitation order
Product Type (Level 1)
E Cardiovascular Medicine Science
Product Type (Level 2)
E.0005.
Import Information
import
Dates and status
Registration Date
Mar 19, 2021
Expiry Date
Mar 19, 2026
About this record

Access comprehensive regulatory information for "Bersen" non-compliant coronary balloon catheter in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 74b7ce7fc3c3864a25d20a7adb9d5878 and manufactured by BIOSENSORS EUROPE SA;; BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTD.. The authorized representative in Taiwan is K&C MEDICAL CO., LTD..

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