Taiwan FDA registration 97198cc16aa31e12bdd4b59808aeffbf

Zhenshu Scar Care Silicone Sheet (Unsterilized)

TW: 珍舒敷疤痕護理矽膠片(未滅菌)

Taiwan·Risk Class 1·Ekendu GmbH;; Zhuohe Enterprise Co., Ltd. (Wugu Factory)·Registered Jul 26, 2023 – Jul 26, 2028Active

Registration details

Analysis ID: 97198cc16aa31e12bdd4b59808aeffbf

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: Jul 26, 2023
Expiry Date: Jul 26, 2028

About this record

Access comprehensive regulatory information for Zhenshu Scar Care Silicone Sheet (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 97198cc16aa31e12bdd4b59808aeffbf 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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