Taiwan FDA registration 8ff95656bf3afd10f89d5cdf23faeaae

"Huazhi" scar care silicone sheet (unsterilized)

TW: “華植”疤痕護理矽膠片 (未滅菌)

Taiwan·Risk Class 1·Zhuohe Enterprise Co., Ltd. (Wugu Factory)·Registered Sep 24, 2014 – Sep 24, 2024Expired

Registration details

Analysis ID: 8ff95656bf3afd10f89d5cdf23faeaae

Company information

Manufacturer: Zhuohe Enterprise Co., Ltd. (Wugu Factory)
Manufacturer Country: Taiwan, Province of China
Authorized Representative: Huazhi Biotechnology Investment 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: Sep 24, 2014
Expiry Date: Sep 24, 2024

About this record

Access comprehensive regulatory information for "Huazhi" 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 8ff95656bf3afd10f89d5cdf23faeaae and manufactured by Zhuohe Enterprise Co., Ltd. (Wugu Factory). The authorized representative in Taiwan is Huazhi Biotechnology Investment Co., Ltd.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.