Restylane Volyme - Taiwan Registration 27f81a53f5f52d003b06cf1eb74aaa18
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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Device Details
Registration Details
27f81a53f5f52d003b06cf1eb74aaa18
Ministry of Health Medical Device Import No. 029749
DHA05602974903
Product Details
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.
I General and plastic surgical devices
I0007 Hyaluronic acid implants
Imported from abroad
Dates and Status
Aug 28, 2017
Aug 28, 2027