Taiwan FDA registration 0eabff78945f72f5f0faf9f659e00b9c

"CHANG HSIN BIOTECH" Isolation Gowns (Non-Sterile)

TW: "長欣生技" 隔離衣 (未滅菌)

Taiwan·Risk Class 1·MD·CHANG HSIN BIOTECH CO., LTD.·Registered Jun 09, 2020 – Jun 09, 2025Expired

Registration details

Analysis ID: 0eabff78945f72f5f0faf9f659e00b9c
License Form: Ministry of Health Medical Device Manufacturing No. 008380

Company information

Manufacturer: CHANG HSIN BIOTECH CO., LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: CHANG HSIN BIOTECH CO., LTD.

Product details

Intended Use: Limited to the first-level identification range of the Measures for the Administration of Medical Devices "Medical Clothing (I.4040)".
Product Type (Level 1): I General and plastic surgical devices
Product Type (Level 2): I4040 Medical clothing
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Jun 09, 2020
Expiry Date: Jun 09, 2025

About this record

Access comprehensive regulatory information for "CHANG HSIN BIOTECH" Isolation Gowns (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 0eabff78945f72f5f0faf9f659e00b9c and manufactured by CHANG HSIN BIOTECH CO., LTD.. The authorized representative in Taiwan is CHANG HSIN BIOTECH CO., LTD..

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.