Singapore HSA registration DE0013120
IVY Biomedical Cardiac Trigger Monitor (Model 7800)
Singapore·CLASS C·Ivy Biomedical Systems, Inc.·Registered June 10, 2013Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Cardiovascular
- HSA Product Code
- HSAMDC00104
- HS Code
- 90181100
Registration information
- Registration Number
- DE0013120
- Registration Date
- June 10, 2013
- Change Notification Approval Date
- July 14, 2021
- Retention Due Date
- June 09, 2025
Product description
The Ivy Biomedical Model 7000 Series Cardiac Trigger Monitors are simple to use instruments for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization
Product Owner
- Short Name
- Ivy Biomedical
- Address
- 11 Business Park Drive, Branford, CT 06405, UNITED STATES
Registrant
- Address
- 211 HENDERSON ROAD, 211 HENDERSON, #08-02, SINGAPORE 159552
Importer
- Address
- 211 HENDERSON ROAD, 211 HENDERSON, #08-02, SINGAPORE 159552
Model information
- Model Name(s)
- Adapter Cable (41’) Recorder paper, pack of 10 rolls NuPrep Gel 4 oz USB memory stick with ECG viewer software Roll Stand Set of four lead wires, 36” long, grabber, radiotranslucent (US color code) Set of four lead wires, 30” long, grabber, radiotranslucent (EU color code) Set of four lead wires, 36” long, grabber, radiotranslucent (EU color code) ECG trunk cable, 4 lead, shielded, AHA/IEC, 10 ft. ECG Electrodes, adult, 10x4/pkg, 10% KCI, bag Cord Set, Continental Europe (12') Cardiac Trigger Monitor 7800 Cardiac Trigger Monitor 7800
- Model Identifier(s)
- 2804-00-01 590035 590291 590386 590441 590442 590451 590452 590478 590494 610020 Ivy Part number: 3304-07-15 Ivy Part number: 3304-21-15
About this record
Access comprehensive regulatory information for IVY Biomedical Cardiac Trigger Monitor (Model 7800) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0013120 and owned by Ivy Biomedical Systems, Inc.. The device was registered on June 10, 2013.
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.
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