Taiwan FDA registration df6e674bd4f87f9c7c5e6332394c6444

Jane Shu Silicone Scar Patch (Infected)

TW: 珍舒敷矽膠疤痕貼片 (未滅菌)

Taiwan·Risk Class 1·Ekendu GmbH;; Zhuohe Enterprise Co., Ltd. (Wugu Factory)·Registered Mar 10, 2020 – Mar 10, 2025Expired

Registration details

Analysis ID: df6e674bd4f87f9c7c5e6332394c6444

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: Contract manufacturing;; Domestic

Dates and status

Registration Date: Mar 10, 2020
Expiry Date: Mar 10, 2025

About this record

Access comprehensive regulatory information for Jane Shu Silicone Scar Patch (Infected) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number df6e674bd4f87f9c7c5e6332394c6444 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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