Taiwan FDA registration ca01462e16cd4915a7896a9392212d34

"Kornit" medical mask (unsterilized)

TW: “康麗”醫用口罩(未滅菌)

Taiwan·Risk Class 1·Huasen Biotechnology Co., Ltd. Plant 2;; Kornit Plastic Co., Ltd·Registered Mar 24, 2022 – Mar 24, 2027Cancelled

Registration details

Analysis ID: ca01462e16cd4915a7896a9392212d34

Company information

Manufacturer: Huasen Biotechnology Co., Ltd. Plant 2;; Kornit Plastic Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: PROMETAL INDUSTRIES 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: QMS/QSD;; 委託製造;; 國產

Dates and status

Registration Date: Mar 24, 2022
Expiry Date: Mar 24, 2027
Cancellation Date: Jan 03, 2023

Cancellation information

Status: Logged out
Reason: 自請註銷

About this record

Access comprehensive regulatory information for "Kornit" 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 ca01462e16cd4915a7896a9392212d34 and manufactured by Huasen Biotechnology Co., Ltd. Plant 2;; Kornit Plastic Co., Ltd. The authorized representative in Taiwan is PROMETAL INDUSTRIES CO., LTD..

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