Taiwan FDA registration 5427c161a626b0e715916a295349334d

"Inken" medical mask (unsterilized)

TW: 〝英肯〞醫用口罩 (未滅菌)

Taiwan·Risk Class 1·Zhaohui Industrial Co., Ltd. Chiayi Factory·Registered Jan 15, 2013 – Jan 15, 2023Expired

Registration details

Analysis ID: 5427c161a626b0e715916a295349334d

Company information

Manufacturer: Zhaohui Industrial Co., Ltd. Chiayi Factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: Inken Instruments Co., Ltd

Product details

Intended Use: Limited to the first-level identification range of the Measures for the Administration of Medical Devices "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: Contract manufacturing;; Domestic

Dates and status

Registration Date: Jan 15, 2013
Expiry Date: Jan 15, 2023

About this record

Access comprehensive regulatory information for "Inken" 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 5427c161a626b0e715916a295349334d and manufactured by Zhaohui Industrial Co., Ltd. Chiayi Factory. The authorized representative in Taiwan is Inken Instruments 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.