Vietnam MOH registration 230002307/PCBB-HN

Treadmill Exercise Electrocardiography System

VN: Hệ thống điện tim gắng sức thảm lăn

Vietnam·Risk Class TTBYT Loại B·CardioTEST Alfa System B612·ASPEL S.A.·Registered Sep 18, 2023

Registration details

Analysis ID: 230002307/PCBB-HN
Submission ID: 000.00.19.H26-230710-0039
Product Type: CardioTEST Alfa System B612

Company information

Manufacturer: ASPEL S.A.

Technical details

Intended Use: CardioTEST software is designed to perform ECG stress tests and classical rest tests. The B612 treadmill is designed for use in cardiac rehabilitation and to perform stress tests on adult and pediatric patients in clinics, hospitals, outpatient centers, and specialized healthcare facilities, where access is controlled and monitored by a responsible individual.

Dates and status

Registration Date: Sep 18, 2023

About this record

Access comprehensive regulatory information for Treadmill Exercise Electrocardiography System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 230002307/PCBB-HN and manufactured by ASPEL S.A..

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