Taiwan FDA registration 54a3eb8a346379ece416191e6e7e43bc
"Lina" catheter fixation device (sterilization)
TW: "利納" 導管固定裝置 (滅菌)
Registration details
- Analysis ID
- 54a3eb8a346379ece416191e6e7e43bc
- Customs Code
- DHA09401634902
Company information
- Manufacturer
- LiNA Medical Polska sp.z.o.o.;; LINA MEDICAL APS
- Manufacturer Country
- Poland;;Denmark
- Authorized Representative
- HOPE SING MEDICAL INSTRUMENTS CO., LTD.
Product details
- Intended Use
- Limited to the first level recognition range of endovascular catheter fixation device (J.5210) of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- J General hospital and personal use equipment
- Product Type (Level 2)
- J.5210 血管內導管固定裝置
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Mar 31, 2016
- Expiry Date
- Mar 31, 2021
- Cancellation Date
- Sep 23, 2023
Cancellation information
- Status
- Logged out
- Reason
- 自行鍵入
About this record
Access comprehensive regulatory information for "Lina" catheter fixation device (sterilization) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 54a3eb8a346379ece416191e6e7e43bc and manufactured by LiNA Medical Polska sp.z.o.o.;; LINA MEDICAL APS. The authorized representative in Taiwan is HOPE SING MEDICAL INSTRUMENTS CO., LTD..
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