Vietnam MOH registration 2402831ĐKLH/BYT-HTTB

Digital Fluoroscopic Radiography Machine

VN: Máy chụp X-quang nhũ ảnh kỹ thuật số

Vietnam·Risk Class TTBYT Loại C·RMF-2000·DRTECH Corporation·Registered Oct 22, 2024

Registration details

Analysis ID: 2402831ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230821-0007
Product Type: RMF-2000

Company information

Manufacturer: DRTECH Corporation
Manufacturer Country: REPUBLIC OF
Product Owner: DRTECH Corporation
Authorized Representative: CÔNG TY TNHH VẠN NIÊN

Technical details

Intended Use: This system is used for the diagnosis of mammography screening. RMF-2000 acquires digital mammography images for the diagnosis of breast cancer. RMF-2000 is designed to be used in the same clinical application as the 2D screening mammography systems. It performs X-ray screening tests of the left and right breasts of the patient to obtain the images. In addition, RMF-2000 can be used to provide more accurate diagnosis of the breast

Dates and status

Registration Date: Oct 22, 2024

About this record

Access comprehensive regulatory information for Digital Fluoroscopic Radiography Machine 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 2402831ĐKLH/BYT-HTTB and manufactured by DRTECH Corporation. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.

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