Vietnam MOH registration 2402655ĐKLH/BYT-HTTB

The Chip-based Tumor Block Localization Module

VN: Bộ đặt chip định vị khối u vú

Vietnam·Risk Class TTBYT Loại C·SCOUT Reflector and Delivery System·Merit Medical Systems, Inc.·Registered Oct 02, 2024

Registration details

Analysis ID: 2402655ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231113-0008
Product Type: SCOUT Reflector and Delivery System
Product Code: SSR05-01; SSR75-01; SSR75S-01; SSR10-01

Company information

Manufacturer: Merit Medical Systems, Inc.
Manufacturer Country: UNITED STATES
Product Owner: Merit Medical Systems, Inc.
Authorized Representative: CÔNG TY TNHH DƯỢC PHẨM VÀ TRANG THIẾT BỊ Y TẾ HOÀNG ĐỨC

Technical details

Intended Use: The SCOUT Reflector Positioning Chip is placed subcutaneously into the soft tissue (>30 days) to mark the location of the intended resection or the location of the soft tissue that is intended to be resected by surgery. By using image guidance (such as ultrasound, MRI, or X-ray) or non-image guidance (the SCOUT Tumor Localization System), the SCOUT Reflector Positioning Chip will be located and resected along with the target tissue. The SCOUT Tumor Localization System is designed to detect and determine the location of the SCOUT Reflector Positioning Chip that has been implanted at the location of the intended resection or the location of the soft tissue that is intended to be resected by surgery, without the need for image guidance. The SCOUT Reflector Positioning Chip has an approximate length of 12 mm and is installed in a 16 GA needle. The SCOUT Reflector Positioning Chip is designed with a radar chirp signal response feature of the SCOUT Probe. Therefore, the SCOUT Reflector Positioning Chip will emit a detectable signal compared to the surrounding tissue when illuminated by the SCOUT Probe. The signal strength is directly related to the distance from the SCOUT Reflector Positioning Chip. Refer to the SCOUT Control Panel User Guide for the detection range. The optimal technique to detect the SCOUT Reflector Positioning Chip with the SCOUT Probe includes positioning the patient in the supine position. The SCOUT Reflector Positioning Chip can be visualized in ultrasound, MRI, and X-ray guidance images. The SCOUT Breast Tumor Localization System Kit includes a plastic handle and a 16 GA needle. The SCOUT Reflector Positioning Chip is pre-installed inside the needle. When the button is activated, the needle retracts into the handle, thereby releasing the SCOUT Reflector Positioning Chip.

Dates and status

Registration Date: Oct 02, 2024

About this record

Access comprehensive regulatory information for The Chip-based Tumor Block Localization Module 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 2402655ĐKLH/BYT-HTTB and manufactured by Merit Medical Systems, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH DƯỢC PHẨM VÀ TRANG THIẾT BỊ Y TẾ HOÀNG ĐỨC.

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