Pure Global
Singapore HSA registration DE0503520

IVY Biomedical Cardiac Trigger Monitor 7600

Singapore flagSingapore·CLASS C·Ivy Biomedical Systems, Inc.·Registered August 27, 2019
Device classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0503520
Registration Date
August 27, 2019
Change Notification Approval Date
October 03, 2024
Retention Due Date
August 26, 2025
Product description
The Ivy Biomedical Model 7000 Series Cardiac Trigger Monitors are simple-to-use instruments for monitoring ECG and Heart Rate. They are designed for use in the ICU, CCU and operating room conditions. They can sound an alarm when HR falls outside of the preset limits. They provide an output pulse, synchronised to the R-wave for use in applications requiring precision R-wave synchronisation.
Product Owner
Name
Ivy Biomedical Systems, Inc.
Short Name
Ivy Biomedical Systems, Inc.
Address
11 Business Park Drive, Branford, CT06405, Connecticut, UNITED STATES
Registrant
Name
ANGEION MEDICAL INTERNATIONAL PTE. LTD.
Address
100 PASIR PANJANG ROAD, 100 PASIR PANJANG, #05-02, SINGAPORE 118518
Importer
Name
ANGEION MEDICAL INTERNATIONAL PTE. LTD.
Address
100 PASIR PANJANG ROAD, 100 PASIR PANJANG, #05-02, SINGAPORE 118518
Model information
Model Name(s)
Cardiac Trigger Monitor 7600
Model Identifier(s)
00816396020252
About this record

Access comprehensive regulatory information for IVY Biomedical Cardiac Trigger Monitor 7600 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503520 and owned by Ivy Biomedical Systems, Inc.. The device was registered on August 27, 2019.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C