Taiwan FDA registration 671d8ae4787276c0bb6bd6fb1112de25

"Guangho" non-heavy respiration breathing mask (unsterilized)

TW: "廣鎬" 非重吸入式呼吸面罩 (未滅菌)

Taiwan·Risk Class 1·OMNIMATE ENTERPRISE CO., LTD.·Registered Oct 28, 2015 – Oct 28, 2025Expired

Registration details

Analysis ID: 671d8ae4787276c0bb6bd6fb1112de25

Company information

Manufacturer: OMNIMATE ENTERPRISE CO., LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: OMNIMATE ENTERPRISE 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: Domestic

Dates and status

Registration Date: Oct 28, 2015
Expiry Date: Oct 28, 2025

About this record

Access comprehensive regulatory information for "Guangho" non-heavy respiration 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 671d8ae4787276c0bb6bd6fb1112de25 and manufactured by OMNIMATE ENTERPRISE CO., LTD.. The authorized representative in Taiwan is OMNIMATE ENTERPRISE CO., LTD..

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