Taiwan FDA registration b057fcb316f625319bd937ed8618ade5

"Huazhi" scar care silicone gel (sterilized)

TW: "華植" 疤痕護理矽凝膠 (滅菌)

Taiwan·Risk Class 1·Zhuohe Enterprise Co., Ltd. (Wugu Factory)·Registered Sep 19, 2016 – Sep 19, 2021Cancelled

Registration details

Analysis ID: b057fcb316f625319bd937ed8618ade5

Company information

Manufacturer: Zhuohe Enterprise Co., Ltd. (Wugu Factory)
Manufacturer Country: Taiwan, Province of China
Authorized Representative: Huazhi Biotechnology Investment Co., Ltd

Product details

Intended Use: Limited to the first-level recognition range of the Measures for the Administration of Medical Devices "Scar Treatment Silicone Products (I.4025)".
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4025 Silicone products for scar treatment
Import Information: QMS/QSD;; 國產;; 委託製造

Dates and status

Registration Date: Sep 19, 2016
Expiry Date: Sep 19, 2021
Cancellation Date: Oct 06, 2023

Cancellation information

Status: Logged out
Reason: 自行鍵入

About this record

Access comprehensive regulatory information for "Huazhi" scar care silicone gel (sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b057fcb316f625319bd937ed8618ade5 and manufactured by Zhuohe Enterprise Co., Ltd. (Wugu Factory). The authorized representative in Taiwan is Huazhi Biotechnology Investment Co., Ltd.

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