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(CE & FDA) Dynamic ECG Systems Holter (AM-5000)
Negotiable
1 Set

Product profile

Customization

Available

Classification

Physiological Functions of Diagnosis and Monitoring Equipment

Type

ECG

Model NO.

AM-5000

Certification

CE, FDA, ISO13485

Group

All

Screen

1.8'' OLED

Transport Package

Carton

Specification

CE, FDA

Trademark

AMISMED

Origin

China

HS Code

9018110000

Key features

12-Lead System Compatibility: Adapts international standard 12-lead system for continuous ECG recording.
24-Hour Continuous Monitoring: Records ECG waves continuously for 24 hours with high precision.
Advanced Pacemaker Analysis: Supports AAI, VVI, DDD and other pacing modules for accurate analysis.
Comprehensive Arrhythmia Detection: Over 10 templates plus user-defined options identify various pathologic waveforms.
Sleep Apnea Risk Prediction: Unique 'Sleep breath pause syndrome analysis' predicts sleep apnea risks.
Heart Rate Variability Analysis: Analyzes short-range (5 min), long-range (1 hour), and 24-hour HRV.
High-Capacity Data Storage: Inbuilt TF card supports up to 2GB uncompressed original data storage.
Fast Case Review: Average review time per case is less than 40 seconds via USB 2.0 interface.

Company profile

Business Type: Manufacturer/Factory, Trading Company, OtherAverage Response Time: ≤8.58h

AI-Powered supplier vetting

SummaryNanjing AMIS Medical Technology Co., Ltd. is a China-based limited company in Jiangsu that identifies as both a trading company and manufacturer/factory. It supplies hospital equipment, surgical products, disposables, and related medical devices, with stated exports across multiple global regions. The supplier reports ISO 13485 and ISO 9001 management-system certifications, two production lines, 6–10 R&D engineers, and 6–10 quality-control staff. It claims more than 10 years of export experience and offers stated lead times of within 15 working days in both peak and off-peak periods. Evidence supports established product, export, and quality-system capabilities, but the provided information does not sufficiently verify financial strength, customization capability, or specific customer performance cases.
Supplier typeThe supplier is identified as a limited company in China and is classified as both a trading company and manufacturer/factory. Its stated business covers manufacturing and marketing hospital equipment, surgical products, and disposable items, indicating a mixed manufacturing-and-trading operating model.
CertificationsThe supplier states that its products are certified under ISO and CE systems and specifically lists ISO 13485 and ISO 9001 management-system certifications. These statements provide explicit evidence of relevant quality and medical-device management certifications, although certificate scope and validity details are not provided.
After-Sales capabilityThe supplier explicitly promotes good after-sales service, kind service, and a long-term customer relationship, and states that it aims to provide required service and support customer success. However, no concrete service infrastructure, response times, warranty terms, or service personnel details are provided.
Production capacityThe supplier reports two production lines, 6–10 quality-control staff, more than 10 years of export experience, and stated order fulfillment within 15 working days in both peak and off-peak seasons. It also offers production-processing and inspection materials, supporting operational capability, although capacity limits and independent verification are not provided.

Product Q&A

Q:What is the recording duration of the AM-5000?
A:
The system can record ECG waves continuously for 24 hours.
Q:Does the device support 12-lead ECG recording?
A:
Yes, it adapts the international standard 12-lead system.
Q:Can the device analyze pacemaker signals?
A:
Yes, it includes powerful pacemaker analysis for AAI, VVI, DDD, and other modules.
Q:What is the maximum storage capacity?
A:
The inbuilt TF card supports a maximum capability of 2GB for uncompressed data.
Q:How long does it take to review a single case?
A:
The average review time for a single case is less than 40 seconds.

Send Inquiry

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