GUDIDData
eudamed_udi Primary ID: +M582NEMCA1610

NEMCA161 (UDI +M582NEMCA1610)

Manufactured by NorthEast Monitoring, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for NEMCA161 - Primary ID +M582NEMCA1610

Device Regulatory Overview

The NEMCA161 (Model/Catalog Number: NEMCA161) is a medical device manufactured by NorthEast Monitoring, Inc.. This product is indexed under FDA Product Code / Category Classification Z12030680 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
NEMCA161
Product Code / EMDN
Z12030680
Device Name
DR400 patient cable
Database Sync Date
2026-08-09 16:48:12

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 NEMCA161?

The registered manufacturer of record for NEMCA161 is NorthEast Monitoring, Inc..

What is the Primary UDI-DI identifier for NEMCA161?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is +M582NEMCA1610.

What classification code is assigned to this device?

This device is registered under product classification code Z12030680.

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