Taiwan FDA registration 67262accf89e3013f386a09e8f96a856

"Bio-Kil" Medical Mask (Unsterilized)

TW: “Bio-Kil” 醫療口罩 (未滅菌)

Taiwan·Risk Class 1·CHAMPAK ENTERPRISE COMPANY LTD.·Registered Jan 24, 2014 – Jan 24, 2024Expired

Registration details

Analysis ID: 67262accf89e3013f386a09e8f96a856

Company information

Manufacturer: CHAMPAK ENTERPRISE COMPANY LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: ST.JUSTINE CORPORATION

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: Domestic;; Contract manufacturing

Dates and status

Registration Date: Jan 24, 2014
Expiry Date: Jan 24, 2024

About this record

Access comprehensive regulatory information for "Bio-Kil" 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 67262accf89e3013f386a09e8f96a856 and manufactured by CHAMPAK ENTERPRISE COMPANY LTD.. The authorized representative in Taiwan is ST.JUSTINE CORPORATION.

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