Taiwan FDA registration bc498ce1da49169ac80306a873331107

One heart and one three-dimensional medical mask (unsterilized)

TW: 一心一罩立體醫用口罩(未滅菌)

Taiwan·Risk Class 1·Eting Enterprise Co., Ltd. Wen Factory·Registered Aug 26, 2021 – Aug 26, 2026Active

Registration details

Analysis ID: bc498ce1da49169ac80306a873331107

Company information

Manufacturer: Eting Enterprise Co., Ltd. Wen Factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: YI TING NON-WOVEN CO., LTD.

Product details

Intended Use: Limited to the first level identification range of medical equipment classification and grading management measures "Medical clothing (I.4040)".
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4040 Clothing for medical purposes
Import Information: 國產;; QMS/QSD

Dates and status

Registration Date: Aug 26, 2021
Expiry Date: Aug 26, 2026

About this record

Access comprehensive regulatory information for One heart and one three-dimensional medical 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 bc498ce1da49169ac80306a873331107 and manufactured by Eting Enterprise Co., Ltd. Wen Factory. The authorized representative in Taiwan is YI TING NON-WOVEN CO., LTD..

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