GUDIDData
eudamed_udi Primary ID: M582AnalysisSoftwareH4

Analysis Software (UDI M582AnalysisSoftwareH4)

Manufactured by NorthEast Monitoring, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Analysis Software - Primary ID M582AnalysisSoftwareH4

Device Regulatory Overview

The Analysis Software (Model/Catalog Number: Holter LX Analysis) is a medical device manufactured by NorthEast Monitoring, Inc.. This product is indexed under FDA Product Code / Category Classification C020599 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
Holter LX Analysis
Product Code / EMDN
C020599
Device Name
Analysis Software
Database Sync Date
2026-08-09 16:46:18

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of Analysis Software?

The registered manufacturer of record for Analysis Software is NorthEast Monitoring, Inc..

What is the Primary UDI-DI identifier for Analysis Software?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is M582AnalysisSoftwareH4.

What classification code is assigned to this device?

This device is registered under product classification code C020599.

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