Taiwan FDA registration f33a61ecd912c5311df65d18840fcd5e

Yuraksu Scar Care Silicone Sheet (Non-Sterilized)

TW: 優樂敷疤痕護理矽膠片(未滅菌)

Taiwan·Risk Class 1·Ekendu GmbH;; Zhuohe Enterprise Co., Ltd. (Wugu Factory)·Registered Aug 19, 2024 – Aug 19, 2029Active

Registration details

Analysis ID: f33a61ecd912c5311df65d18840fcd5e

Company information

Manufacturer: Ekendu GmbH;; Zhuohe Enterprise Co., Ltd. (Wugu Factory)
Manufacturer Country: Taiwan, Province of China
Authorized Representative: ICANDO BIOTECH CO., LTD.

Product details

Intended Use: It is limited to the scope of first-level identification of the "Silicone Products for Scar Treatment (I.4025)" of the Administrative Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4025 Silicone products for scar treatment
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Aug 19, 2024
Expiry Date: Aug 19, 2029

About this record

Access comprehensive regulatory information for Yuraksu Scar Care Silicone Sheet (Non-Sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number f33a61ecd912c5311df65d18840fcd5e and manufactured by Ekendu GmbH;; Zhuohe Enterprise Co., Ltd. (Wugu Factory). The authorized representative in Taiwan is ICANDO BIOTECH CO., LTD..

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