Taiwan FDA registration e09b142b06d3787face176dec924ca83

Zhenshu Scar Gel (Sterilized)

TW: 珍舒敷疤痕凝膠 (滅菌)

Taiwan·Risk Class 1·Ekendu GmbH;; Zhuohe Enterprise Co., Ltd. (Wugu Factory)·Registered Oct 07, 2020 – Oct 07, 2025Expired

Registration details

Analysis ID: e09b142b06d3787face176dec924ca83

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: Limited to the first level identification scope of the Measures for the Classification and Grading 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;; 委託製造;; 國產

Dates and status

Registration Date: Oct 07, 2020
Expiry Date: Oct 07, 2025

About this record

Access comprehensive regulatory information for Zhenshu Scar 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 e09b142b06d3787face176dec924ca83 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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