Taiwan FDA registration 77b7185c9740a03cf894a155fa2c9a17

"Xingjie" non-heavy breathing mask (unsterilized)

TW: “星捷”非重吸入式呼吸面罩(未滅菌)
Taiwan flagTaiwan·Risk Class 1·SEN JEWEL TECHNOLOGY CO., LTD.·Registered Mar 02, 2022 – Mar 02, 2027Active
Registration details
Analysis ID
77b7185c9740a03cf894a155fa2c9a17
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
SEN JEWEL TECHNOLOGY CO., LTD.
Product details
Intended Use
Limited to the first level of identification scope of the "Non-heavy inhalation breathing mask (D.5570)" of the Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1)
D Anesthesiology
Product Type (Level 2)
D.5570 非重吸入式呼吸面罩
Import Information
QMS/QSD;; 國產
Dates and status
Registration Date
Mar 02, 2022
Expiry Date
Mar 02, 2027
About this record

Access comprehensive regulatory information for "Xingjie" non-heavy breathing mask (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 77b7185c9740a03cf894a155fa2c9a17 and manufactured by SEN JEWEL TECHNOLOGY CO., LTD.. The authorized representative in Taiwan is SEN JEWEL 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.

Free DatabasePowered by Pure Global AI89,000+ Devices