Radiofrequency and Steam Prostate Enlargement Treatment Machine - Vietnam Registration 2403352ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Radiofrequency and Steam Prostate Enlargement Treatment Machine in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403352ĐKLH/BYT-HTTB and manufactured by Boston Scientific. The authorized representative in Vietnam is CÔNG TY TNHH BOSTON SCIENTIFIC VIỆT NAM.
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Device Details
Registration Details
2403352ĐKLH/BYT-HTTB
000.00.04.G18-221115-0026
Theo theo phụ lục
Theo phụ lục
Technical Details
The Rezum Energy Generator is intended to be used in conjunction with the Rezum Energy Delivery System. The Rezūm System aims to reduce symptoms of obstruction and decrease the size of the prostate gland associated with benign prostatic hyperplasia (BPH). It is indicated for men with a prostate volume ≥ 30 cm3. The Rezūm System is also indicated for the treatment of central zone and/or middle lobe BPH.
Dates and Status
Nov 06, 2024