GUDIDData
eudamed_udi Primary ID: +M582NEMEL0020

NEMEL002 (UDI +M582NEMEL0020)

Manufactured by NorthEast Monitoring, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for NEMEL002 - Primary ID +M582NEMEL0020

Device Regulatory Overview

The NEMEL002 (Model/Catalog Number: NEMEL002) is a medical device manufactured by NorthEast Monitoring, Inc.. This product is indexed under FDA Product Code / Category Classification C020501 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
NEMEL002
Product Code / EMDN
C020501
Device Name
NEMEL electrode patch used with the DR400
Database Sync Date
2026-08-09 18:19:10

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 NEMEL002?

The registered manufacturer of record for NEMEL002 is NorthEast Monitoring, Inc..

What is the Primary UDI-DI identifier for NEMEL002?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is +M582NEMEL0020.

What classification code is assigned to this device?

This device is registered under product classification code C020501.

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