Vietnam MOH registration 2403614ĐKLH/BYT-HTTB

MRI-Compliant Fluorescent Drug Injection Pump

VN: Bơm tiêm thuốc cản quang có tương thích MRI

Vietnam·Risk Class TTBYT Loại C·MEDRAD MRXperion MR Injection System with Certegra Workstation·Bayer Medical Care Inc.·Registered Nov 19, 2024

Registration details

Analysis ID: 2403614ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220418-0021
Product Type: MEDRAD MRXperion MR Injection System with Certegra Workstation
Product Code: MRXP 200

Company information

Manufacturer: Bayer Medical Care Inc.
Manufacturer Country: UNITED STATES
Authorized Representative: CÔNG TY TNHH BAYER VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Nov 19, 2024

About this record

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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