Taiwan FDA registration 6de6eca6014dd85cae6f604400e914f1

"New Guangye" non-heavy respiration respirator (unsterilized)

TW: "新廣業" 非重吸入式呼吸面罩 (未滅菌)

Taiwan·Risk Class 1·HSINER CO., LTD.·Registered Mar 04, 2016 – Mar 04, 2026Expired

Registration details

Analysis ID: 6de6eca6014dd85cae6f604400e914f1

Company information

Manufacturer: HSINER CO., LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: HSINER CO., LTD.

Product details

Intended Use: It is limited to the first level of identification of "respirator tubing (D.5975)", "air bag (D.5320)" and "non-re-inhaling respirator mask (D.5570)" in the classification and grading management measures for medical devices.
Product Type (Level 1): D Anesthesiology
Product Type (Level 2): D.5975 Respirator Tubing;; D.5570 Non-re-inhaling respirators;; D.5320 Air sacs
Import Information: Domestic

Dates and status

Registration Date: Mar 04, 2016
Expiry Date: Mar 04, 2026

About this record

Access comprehensive regulatory information for "New Guangye" non-heavy respiration respirator (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 6de6eca6014dd85cae6f604400e914f1 and manufactured by HSINER CO., LTD.. The authorized representative in Taiwan is HSINER CO., LTD..

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