Vietnam MOH registration 2402042ĐKLH/BYT-HTTB

Conformal Post-Load Radiotherapy Treatment System

VN: Hệ thống điều trị xạ trị áp sát tải sau

SagiNova HDR Afterloader System

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·BEBIG Medical GmbH·Registered Aug 27, 2024

Registration details

Analysis ID: 2402042ĐKLH/BYT-HTTB
Submission ID: 18007388/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: BEBIG Medical GmbH
Manufacturer Country: Theo theo phụ lục
Product Owner: BEBIG Medical GmbH
Authorized Representative: CÔNG TY TNHH TRANSMEDIC HEALTHCARE

Technical details

Intended Use: SagiNova is a high-dose-rate postloading system designed for the application of radiation therapy to specific regions of the body with a remotely controlled radiation source. It is used to treat positions in the body such as interstitial sites, intraluminal sites, and during surgery or on the skin. The system is intended for use by medical professionals trained in radiation oncology.

Dates and status

Registration Date: Aug 27, 2024

About this record

Access comprehensive regulatory information for Conformal Post-Load Radiotherapy Treatment System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2402042ĐKLH/BYT-HTTB and manufactured by BEBIG Medical GmbH. The authorized representative in Vietnam is CÔNG TY TNHH TRANSMEDIC HEALTHCARE.

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