Vietnam MOH registration 240001446/PCBB-HCM

Electrocardiogram (ECG) Machine

VN: Máy đo điện tâm đồ

Vietnam·Risk Class TTBYT Loại B·7800·Ivy Biomedical Systems, Inc.·Registered Jul 11, 2024

Registration details

Analysis ID: 240001446/PCBB-HCM
Submission ID: 000.00.19.H29-240704-0016
Product Type: 7800

Company information

Manufacturer: Ivy Biomedical Systems, Inc.
Product Owner: Ivy Biomedical Systems, Inc.
Authorized Representative: CÔNG TY TNHH FUJIFILM VIỆT NAM

Technical details

Intended Use: The ECG and heart rate monitoring devices in the 7000 Series by Ivy Biomedical are user-friendly tools for monitoring ECG and heart rate. These devices are designed for use in ICU, CCU, and monitoring rooms. They emit an audible alarm when the heart rate (HR) decreases outside the preset limits. The device provides a synchronized output pulse, synchronized with the R wave, for applications requiring precise R wave synchronization.

Dates and status

Registration Date: Jul 11, 2024

About this record

Access comprehensive regulatory information for Electrocardiogram (ECG) Machine 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 240001446/PCBB-HCM and manufactured by Ivy Biomedical Systems, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH FUJIFILM VIỆT NAM.

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