Singapore HSA registration DE0011708
IVY Biomedical Cardiac Trigger Monitor
Singapore·CLASS C·Ivy Biomedical Systems, Inc.·Registered December 05, 2012Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Cardiovascular
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90181900
Registration information
- Registration Number
- DE0011708
- Registration Date
- December 05, 2012
- Retention Due Date
- December 04, 2025
Product description
The Ivy Biomedical Model 3000 with T‐B option Cardiac Trigger Monitor is intended for monitoring the patient's ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the 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. The Model 3000 with T‐B option is limited to use by trained and qualified medical professionals. This product is not intended for home care monitoring.
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)
- Model 3000 with Options T-A or T-B Operation Manual Adapter Cable (41’) Adapter Cable (8’) CD - Model 3000 with Options T-A or T-B Cardiac Trigger Monitor 3000 Cardiac Trigger Monitor 3000 Recorder paper, pack of 10 rolls Roll stand Set of three leads, 24” long, grabber, radiotranslucent (US color code) ECG patient cable, low noise, three lead (US color code) Set of three leads, 30” long, grabber, radiotranslucent (US color code) Radiotranslucent ECG electrodes, bag of 30 Set of three leads, 24” long, grabber, radiotranslucent (EU color code) ECG patient cable, low noise, three lead (EU color code) USB memory stick with ECG viewer software Set of three leads, 40” long, grabber, radiotranslucent (US color code) Cord Set, Hospital Grade (8’) Cord Set, Continental Europe (12’)
- Model Identifier(s)
- 2718-52-16 2804-00-01 2805-00-01 2836-01-10 3087-21-15 3087-24-15 590035 590297 590318 590323 590341 590342 590376 590381 590386 590398 610007 610020
About this record
Access comprehensive regulatory information for IVY Biomedical Cardiac Trigger Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0011708 and owned by Ivy Biomedical Systems, Inc.. The device was registered on December 05, 2012.
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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