Taiwan FDA registration 114a78e6141e45673bd07cde5a6c6001

"Parkron" scar care silicone sheet (sterilized)

TW: "柏榮" 疤痕護理矽膠片 (滅菌)

Taiwan·Risk Class 1·Zhuohe Enterprise Co., Ltd. (Wugu Factory)·Registered Mar 23, 2016 – Mar 23, 2021Cancelled

Registration details

Analysis ID: 114a78e6141e45673bd07cde5a6c6001

Company information

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

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: 委託製造;; QMS/QSD;; 國產

Dates and status

Registration Date: Mar 23, 2016
Expiry Date: Mar 23, 2021
Cancellation Date: Oct 12, 2023

Cancellation information

Status: Logged out
Reason: 未展延而逾期者

About this record

Access comprehensive regulatory information for "Parkron" 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 114a78e6141e45673bd07cde5a6c6001 and manufactured by Zhuohe Enterprise Co., Ltd. (Wugu Factory). The authorized representative in Taiwan is Pak Wing Biomedical Limited.

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