Vietnam MOH registration 240002118/PCBB-HCM

(Holter ECG Monitoring System)

VN: (Hệ thống) Máy đo điện tim Holter

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Bittium Biosignals Ltd·Registered Sep 18, 2024

Registration details

Analysis ID: 240002118/PCBB-HCM
Submission ID: 000.00.19.H29-240910-0008
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Bittium Biosignals Ltd
Manufacturer Country: Theo theo phụ lục
Product Owner: Bittium Biosignals Ltd
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ Y TẾ ĐỨC NGỌC

Technical details

Intended Use: The device is a wireless ECG monitor, which can be worn and moved, and is externally attached to measure ECG, measure the R-R interval data, and record the patient's movements.

Dates and status

Registration Date: Sep 18, 2024

About this record

Access comprehensive regulatory information for (Holter ECG Monitoring System) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002118/PCBB-HCM and manufactured by Bittium Biosignals Ltd. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ Y TẾ ĐỨC NGỌC.

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