Taiwan FDA registration 2bd75c85916c99943cdd4548d69b9c25

"Bokang" medical mask (unsterilized)

TW: “伯康” 醫用口罩(未滅菌)
Taiwan flagTaiwan·Risk Class 1·Berkang Co., Ltd.;; South Sixth Enterprise Co., Ltd. Kaohsiung Factory·Registered Apr 26, 2022 – Apr 26, 2027Active
Registration details
Analysis ID
2bd75c85916c99943cdd4548d69b9c25
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
HEALTHBOLE 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
委託製造;; QMS/QSD;; 國產
Dates and status
Registration Date
Apr 26, 2022
Expiry Date
Apr 26, 2027
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About this record

Access comprehensive regulatory information for "Bokang" 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 2bd75c85916c99943cdd4548d69b9c25 and manufactured by Berkang Co., Ltd.;; South Sixth Enterprise Co., Ltd. Kaohsiung Factory. The authorized representative in Taiwan is HEALTHBOLE CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Shunyili Industrial Co., Ltd. seven blocks factory, Jingxin Technology Co., Ltd., and 2 recent registrations in the same category. 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.

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