Vietnam MOH registration 2403352ĐKLH/BYT-HTTB

Radiofrequency and Steam Prostate Enlargement Treatment Machine

VN: Máy điều trị phì đại tuyến tiền liệt bằng sóng radio và hơi nước

Vietnam·Risk Class TBYT Loại C·Theo theo phụ lục·Boston Scientific·Registered Nov 06, 2024

Registration details

Analysis ID: 2403352ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-221115-0026
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Boston Scientific
Manufacturer Country: Theo theo phụ lục
Product Owner: Boston Scientific
Authorized Representative: CÔNG TY TNHH BOSTON SCIENTIFIC VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Nov 06, 2024

About this record

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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