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FDA Cleared & CE Certified

Holter Monitors

High-Precision 3-Channel & 12-Channel Ambulatory ECG Recorders for Hospitals, Cardiology Clinics & Global Healthcare Distributors

KAKA Medical Technology Co., Ltd. is a leading master distributor of FDA-approved digital Holter monitoring systems and ambulatory cardiac diagnostic devices. Our advanced Holter solutions feature lightweight, ergonomic hardware paired with AI-assisted software capable of detecting ST-segment deviations, arrhythmias, pacemaker spikes, and Heart Rate Variability (HRV). Engineered for maximum patient compliance and robust clinical accuracy, our devices meet international regulatory standards required by medical procurement officers worldwide.

FDA-Approved Holter Monitoring Systems

Explore our clinically validated range of 3-channel and 12-channel digital Holter recorders designed for continuous 24-hour to 7-day ambulatory ECG data acquisition.

SE-2003 3-Channel Digital Holter System
EDAN Medical

SE-2003 3-Channel Holter System

Compact, waterproof 3-channel ambulatory ECG recorder designed for continuous monitoring up to 7 days on a single AAA battery.

3-Channel Digital Recording
OLED Display Screen
IP27 Waterproof Rating
Pacemaker Detection
FDA 510(k) CE Marked ISO 13485
SE-2012 12-Channel High-Definition Holter System
EDAN Medical

SE-2012 12-Channel Holter System

High-definition 12-lead simultaneous ambulatory ECG recorder engineered for detailed diagnostic cardiology and complex arrhythmia analysis.

Full 12-Lead Simultaneous Acquisition
Up to 10,000 Hz Sampling Frequency
Smart ST Segment & HRV Software
Fast USB Data Transfer
FDA 510(k) CE Marked EMR Compatible
QRS Q200/HE Holter and Event Recorder
QRS Diagnostic

QRS Q200/HE Holter/Event Recorder

Dual-function digital recorder operating as either a 3-channel Holter or a patient-activated Cardiac Event Monitor for extended diagnostic protocols.

Dual Holter / Event Mode
14-Day Extended Event Recording
Single Button Patient Marker
Lightweight & Ergonomic
FDA Approved USA Made CE Certified

Clinical Application & Diagnostic Capabilities

Ambulatory Holter monitoring is the gold standard for evaluating transient cardiac symptoms such as palpitations, unexplained syncope, dizziness, and suspected atrial fibrillation. The diagnostic Holter systems distributed by KAKA Medical Technology Co., Ltd. incorporate advanced signal processing to filter artifacts caused by patient movement, ensuring high-fidelity signal acquisition across long recording periods.

Arrhythmia Auto-Categorization

Automated template matching categorizes Normal, PVC, PAC, Ventricular Couplets, Runs, and Pause events within minutes, reducing physician analysis time by up to 75%.

ST-Segment Elevation & Trend Analysis

Comprehensive 3-channel and 12-channel ST-segment mapping tracks ischemic episodes, myocardial load, and diurnal heart rate variability over continuous 24-hour windows.

Adjustable Pacemaker Detection

Dedicated hardware circuits detect and record single and dual-chamber pacemaker pulses accurately without signal distortion or false artifact triggering.

EHR & HL7 System Integration

Generate customized diagnostic PDF reports or export structured raw data files (DICOM, HL7, XML) for immediate integration into hospital Electronic Health Records.

3-Channel vs. 12-Channel Holter System Comparison

Selecting the optimal Holter configuration depends on clinical requirements, patient volume, and diagnostic focus. Review our technical specification comparison below:

Technical Parameter 3-Channel Digital Holter (SE-2003) 12-Channel HD Holter (SE-2012) Combination Holter/Event (Q200/HE)
Recording Channels 3 Independent Channels 12-Lead Simultaneous 3-Channel Holter / 3-Channel Event
Recording Duration 24 Hours to 7 Days Continuous 24 to 48 Hours Up to 14 Days (Event Mode)
Sampling Frequency Up to 2,000 Hz Up to 10,000 Hz 1,000 Hz
Waterproof Standard IP27 Submersible Design IP27 Water Resistant Water Resistant Enclosure
Display Screen OLED Color Waveform Display OLED Color Waveform Display LCD Status Indicator
Ideal Clinical Setting Primary Care, Outpatient Clinics Cardiology Hospitals, Electrophysiology Transient Symptom Evaluation
Regulatory Compliance FDA 510(k), CE 0123, ISO 13485 FDA 510(k), CE 0123, ISO 13485 FDA Cleared, CE Certified

Why Overseas Medical Distributors Partner With Us

KAKA Medical Technology Co., Ltd. serves as a master export bridge for international medical equipment dealers, hospital purchasing committees, and healthcare group purchasing organizations (GPOs). We streamline international procurement by providing complete product compliance, competitive wholesale pricing, and long-term technical support.

Global Distributor Advantages

  • Regulatory Documentation: Complete export support including FDA 510(k) summary documents, CE Declaration of Conformity, ISO certificates, and Free Sale Certificates (FSC).
  • Factory-Direct Warranty & Spare Parts: 2-year warranty on digital recorders with direct availability of patient lead cables, carrying pouches, and disposable electrodes.
  • Software Licensing & Training: Multi-user analysis software licenses provided without recurring annual fee lock-ins, supported by online engineer training modules.
  • Pre-Shipment Quality Control: Every Holter unit undergoes multi-point signal calibration testing at our facility prior to international dispatch.

Frequently Asked Questions for Medical Buyers

Are software licenses included with Holter hardware purchases?

Yes. KAKA Medical Technology Co., Ltd. provides complete diagnostic software packages alongside Holter hardware. Software licenses include full ST-segment, arrhythmia, HRV, and Pacemaker analysis modules without mandatory monthly subscription fees.

What international quality certifications do your Holter systems hold?

All Holter devices distributed by KAKA Medical Technology Co., Ltd. hold valid FDA 510(k) clearances, CE marks under European Medical Device Regulations, and ISO 13485 quality management certification. Free Sale Certificates (FSC) can be issued for custom clearance in South America, Southeast Asia, the Middle East, and Africa.

Can Holter data be exported to hospital EMR/HIS systems?

Yes. The analysis software bundled with our Holter monitors supports HL7, DICOM, PDF, and XML data export formats, enabling effortless integration into central hospital information systems and digital patient archives.

How does KAKA Medical Technology Co., Ltd. support global warranty service?

We maintain a dedicated technical team to facilitate rapid replacement of lead cables, firmware updates, and hardware repair support. International distributors receive priority spare parts shipping and remote technical assistance.