Taiwan FDA registration 27f81a53f5f52d003b06cf1eb74aaa18

Restylane Volyme

TW: 瑞絲朗-丰采(含利多卡因)

Taiwan·Risk Class 3·MD·Q-MED AB·Registered Aug 28, 2017 – Aug 28, 2027Active

Registration details

Analysis ID: 27f81a53f5f52d003b06cf1eb74aaa18
License Form: Ministry of Health Medical Device Import No. 029749
Customs Code: DHA05602974903

Company information

Manufacturer: Q-MED AB
Manufacturer Country: Sweden
Authorized Representative: GALDERMA HONG KONG LIMITED, TAIWAN BRANCH

Product details

Intended Use: This product can be used to enhance the fullness of facial tissues. This product is recommended for correcting facial volume such as cheeks and chin, depending on the area and tissue support to be treated, this product should be injected into the supraperiostic zone or subcutaneous tissue. Lidocaine is added to the product to reduce pain during therapeutic injections. In an open-labeled, multicenter study of full-face volume loss correction using Restylane Volyme, all subjects showed improvement in full-face volume loss 3 weeks after the last injection, and after 18 months, more than two-thirds of subjects still showed improvement. In another open-label multicenter study evaluating the efficacy and tolerability of Restylane Volyme in facial rejuvenation, most subjects maintained cheek volume for at least 6 months.
Product Type (Level 1): I General and plastic surgical devices
Product Type (Level 2): I0007 Hyaluronic acid implants
Import Information: Imported from abroad

Dates and status

Registration Date: Aug 28, 2017
Expiry Date: Aug 28, 2027

About this record

Access comprehensive regulatory information for Restylane Volyme in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 27f81a53f5f52d003b06cf1eb74aaa18 and manufactured by Q-MED AB. The authorized representative in Taiwan is GALDERMA HONG KONG LIMITED, TAIWAN BRANCH.

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