Taiwan FDA registration e127bd9d6b4d3fca7573860d3257e014

"Chang Gung" atrial fibrillation detection software

TW: “長庚” 心房顫動偵測軟體

Taiwan·Risk Class 2·Chang Gung Medical Technology Co., Ltd. Linkou Factory·Registered Sep 07, 2023 – Sep 07, 2028Active

Registration details

Analysis ID: e127bd9d6b4d3fca7573860d3257e014

Company information

Manufacturer: Chang Gung Medical Technology Co., Ltd. Linkou Factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: CHANG GUNG MEMORIAL HOSPITAL, LINKOU

Product details

Intended Use: Details are as detailed as approved Chinese instructions
Product Type (Level 1): E Cardiovascular Medicine Science
Product Type (Level 2): E.1425 Programmable diagnostic computer
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Sep 07, 2023
Expiry Date: Sep 07, 2028

About this record

Access comprehensive regulatory information for "Chang Gung" atrial fibrillation detection software in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e127bd9d6b4d3fca7573860d3257e014 and manufactured by Chang Gung Medical Technology Co., Ltd. Linkou Factory. The authorized representative in Taiwan is CHANG GUNG MEMORIAL HOSPITAL, LINKOU.

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.