Taiwan FDA registration 1a9ea4022e51dab756b32ea2ce2f8828

"Jinglei" intravascular catheter fixation device (unsterilized)

TW: "精磊" 血管內導管固定裝置 (未滅菌)

Taiwan·Risk Class 1·FORTUNE APPLIED MATERIAL TECHNOLOGY CO., LTD.·Registered Mar 29, 2018 – Mar 29, 2023Expired

Registration details

Analysis ID: 1a9ea4022e51dab756b32ea2ce2f8828

Company information

Manufacturer: FORTUNE APPLIED MATERIAL TECHNOLOGY CO., LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: GENLAB BIOTECH COMPANY

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: Contract manufacturing;; Domestic

Dates and status

Registration Date: Mar 29, 2018
Expiry Date: Mar 29, 2023

About this record

Access comprehensive regulatory information for "Jinglei" intravascular catheter fixation 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 1a9ea4022e51dab756b32ea2ce2f8828 and manufactured by FORTUNE APPLIED MATERIAL TECHNOLOGY CO., LTD.. The authorized representative in Taiwan is GENLAB BIOTECH COMPANY.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.