Holter ECG System - Vietnam Registration 240000533/PCBB-HN
Access comprehensive regulatory information for Holter ECG 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 240000533/PCBB-HN and manufactured by AMEDTEC Medizintechnik Aue GmbH. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN PHÂN PHỐI VÀ ĐẦU TƯ PATCO.
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Device Details
Registration Details
240000533/PCBB-HN
000.00.19.H26-240311-0007
Theo theo phụ lục
Theo phụ lục
Technical Details
Holter monitoring is used for patients who require continuous monitoring from 1 to 168 hours. It is most commonly used for (but not limited to) the following indications: - Evaluation of symptoms of arrhythmia or myocardial ischemia - Evaluation of ECG documentation of treatment response in each patient or group of patients - Evaluation of patients through changes in the ST segment - Evaluation of the response of patients after recovery or after engaging in recreational activities. (e.g., after a heart attack or heart surgery) -Clinical research and epidemiological studies -Evaluation of patients with pacemakers -Reports of changes in heart rate over time and frequency domain -Reports of the QT interval.
Dates and Status
Mar 12, 2024