Taiwan FDA registration 0b17e5092db1a9fc1b1737c103e09feb

“ERDIN” A-V Fistula Needle Set

TW: “愛丁格”動靜脈瘻管針

Taiwan·Risk Class 2·MD·Shande Biochemical Technology Co., Ltd. is loyal to the factory·Registered May 20, 2022 – Oct 16, 2025Expired

Registration details

Analysis ID: 0b17e5092db1a9fc1b1737c103e09feb
License Form: Ministry of Health Medical Device Manufacturing No. 007395

Company information

Manufacturer: Shande Biochemical Technology Co., Ltd. is loyal to the factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: SUNDER BIOMEDICAL TECH. CO., LTD.

Product details

Intended Use: Details are as detailed as approved Chinese instructions
Product Type (Level 1): H Gastroenterology and urology
Product Type (Level 2): H5540 Blood access devices and accessories
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: May 20, 2022
Expiry Date: Oct 16, 2025

About this record

Access comprehensive regulatory information for “ERDIN” A-V Fistula Needle Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0b17e5092db1a9fc1b1737c103e09feb and manufactured by Shande Biochemical Technology Co., Ltd. is loyal to the factory. The authorized representative in Taiwan is SUNDER BIOMEDICAL TECH. CO., LTD..

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