Taiwan FDA registration 548466f06e1d2072b610fec5a00e0158

Pujie medical masks (unsterilized)

TW: 普潔醫用口罩(未滅菌)

Taiwan·Risk Class 1·Kangcheng Biomedical Enterprise Co., Ltd. Taiping Factory;; Dijia Co., Ltd·Registered Dec 12, 2022 – Dec 12, 2027Active

Registration details

Analysis ID: 548466f06e1d2072b610fec5a00e0158

Company information

Manufacturer: Kangcheng Biomedical Enterprise Co., Ltd. Taiping Factory;; Dijia Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: Home Product Inc.

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;; 委託製造

Dates and status

Registration Date: Dec 12, 2022
Expiry Date: Dec 12, 2027

About this record

Access comprehensive regulatory information for Pujie medical masks (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 548466f06e1d2072b610fec5a00e0158 and manufactured by Kangcheng Biomedical Enterprise Co., Ltd. Taiping Factory;; Dijia Co., Ltd. The authorized representative in Taiwan is Home Product Inc..

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