Taiwan FDA registration 16a8d7f3d2c219a58055063c79b40944

“Chang Gung” TN95 Surgical Respirator (Non-sterile)

TW: “長庚”TN95外科手術口罩(未滅菌)

Taiwan·Risk Class 2·MD·Chang Gung Medical Technology Co., Ltd. Linkou Factory·Registered Sep 27, 2023 – Sep 27, 2028Active

Registration details

Analysis ID: 16a8d7f3d2c219a58055063c79b40944
License Form: Ministry of Health Medical Device Manufacturing No. 008103

Company information

Manufacturer: Chang Gung Medical Technology Co., Ltd. Linkou Factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: CHANG GUNG MEDICAL TECHNOLOGY CO., LTD.

Product details

Intended Use: Details are as detailed as approved Chinese instructions
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I4040 Medical clothing
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Sep 27, 2023
Expiry Date: Sep 27, 2028

About this record

Access comprehensive regulatory information for “Chang Gung” TN95 Surgical Respirator (Non-sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 16a8d7f3d2c219a58055063c79b40944 and manufactured by Chang Gung Medical Technology Co., Ltd. Linkou Factory. The authorized representative in Taiwan is CHANG GUNG MEDICAL TECHNOLOGY 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.