MRI-Compliant Fluorescent Drug Injection Pump - Vietnam Registration 2403614ĐKLH/BYT-HTTB
Access comprehensive regulatory information for MRI-Compliant Fluorescent Drug Injection Pump 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 2403614ĐKLH/BYT-HTTB and manufactured by Bayer Medical Care Inc.. The authorized representative in Vietnam is CÔNG TY TNHH BAYER VIỆT NAM.
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Device Details
Registration Details
2403614ĐKLH/BYT-HTTB
000.00.04.G18-220418-0021
MEDRAD MRXperion MR Injection System with Certegra Workstation
MRXP 200
Technical Details
The MR MEDRAD MRXperion Injection System is a distribution system based on the syringe that is designated to distribute the contrast agent and saline solution in MRI procedures. The system is intended for the specific purpose of intravenous injection of the contrast agent in MRI and the injection of saline solution into the human circulatory system for diagnostic studies in MRI applications with MRI machines having magnetic field strengths from 0.7 Tesla to 3.0 Tesla. Only trained medical professionals are authorized to operate this device.
Dates and Status
Nov 19, 2024