Taiwan FDA registration ece8a40617278d8d3d1fbc9013491344

Hydrogel Scar Care Silicone Sheet (Sterilized)

TW: 水凝敷疤痕護理矽膠片 (滅菌)

Taiwan·Risk Class 1·Zhuohe Enterprise Co., Ltd. (Wugu Factory)·Registered Jun 16, 2016 – Jun 16, 2021Cancelled

Registration details

Analysis ID: ece8a40617278d8d3d1fbc9013491344

Company information

Manufacturer: Zhuohe Enterprise Co., Ltd. (Wugu Factory)
Manufacturer Country: Taiwan, Province of China
Authorized Representative: Ruizhi Biomedical Co., Ltd

Product details

Intended Use: Limited to the first-level recognition range of the Measures for the Administration 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: 國產;; QMS/QSD;; 委託製造

Dates and status

Registration Date: Jun 16, 2016
Expiry Date: Jun 16, 2021
Cancellation Date: Jan 02, 2024

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for Hydrogel Scar Care Silicone Sheet (Sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number ece8a40617278d8d3d1fbc9013491344 and manufactured by Zhuohe Enterprise Co., Ltd. (Wugu Factory). The authorized representative in Taiwan is Ruizhi Biomedical Co., Ltd.

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