Taiwan FDA registration 8dc7c9708c35d52c0ed96c655dd720f8

Jane Shu Scar Care Silicone Pen (Non-Sterilized)

TW: 珍舒敷疤痕護理矽膠筆(未滅菌)

Taiwan·Risk Class 1·Ekendu GmbH;; Zhuohe Enterprise Co., Ltd. (Wugu Factory)·Registered Sep 01, 2023 – Sep 01, 2028Active

Registration details

Analysis ID: 8dc7c9708c35d52c0ed96c655dd720f8

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: Domestic;; Contract manufacturing

Dates and status

Registration Date: Sep 01, 2023
Expiry Date: Sep 01, 2028

About this record

Access comprehensive regulatory information for Jane Shu Scar Care Silicone Pen (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 8dc7c9708c35d52c0ed96c655dd720f8 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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