Holter ECG System
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·AMEDTEC Medizintechnik Aue GmbH·Registered Mar 12, 2024- Analysis ID
- 240000533/PCBB-HN
- Submission ID
- 000.00.19.H26-240311-0007
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- AMEDTEC Medizintechnik Aue GmbH
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- AMEDTEC Medizintechnik Aue GmbH
- Authorized Representative
- CÔNG TY CỔ PHẦN PHÂN PHỐI VÀ ĐẦU TƯ PATCO
- Intended Use
- 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.
- Registration Date
- Mar 12, 2024
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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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