gudid Primary ID: M-MR-5PR-050

MEDALink (UDI M-MR-5PR-050)

Manufactured by Rising Eagle Medical LLC

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The MEDALink (Model/Catalog Number: M-MR-5PR-050) is a medical device manufactured by Rising Eagle Medical LLC. This product is indexed under FDA Product Code / Category Classification IKD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: M-MR-5PR-050
Product Code / EMDN: IKD
Device Name: 5 Lead, Pinch, Reusable, Mindray Compatible, 50in, ECG Leadwire, AHA/AAMI, 1/EA
Database Sync Date: 2026-08-09 09:04:02

Full Regulatory Attributes

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{
    "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 MEDALink?

The registered manufacturer of record for MEDALink is Rising Eagle Medical LLC.

What is the Primary UDI-DI identifier for MEDALink?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is M-MR-5PR-050.

What classification code is assigned to this device?

This device is registered under product classification code IKD.

Similar Classification Devices (IKD)

Other Devices by Rising Eagle Medical LLC

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