MEDALink

FDA UDI

Class II (US FDA UDI)

by Rising Eagle Medical

Identity

Trade Name: MEDALink FDA UDI
Generic Name: Electrocardiographic lead set, reusable FDA UDI
Device Name: 5 Lead, Pinch, Reusable, GE Compatible, 50in, ECG Leadwire, AHA/AAMI, 1/EA FDA UDI
Model / Reference: M-GE-5PR-050 FDA UDI
Description: 5 Lead, Pinch, Reusable, GE Compatible, 50in, ECG Leadwire, AHA/AAMI, 1/EA FDA UDI

Identifiers

Catalog Number: M-GE-5PR-050 FDA UDI
Primary DI / UDI-DI: G096MGE5PR0500 FDA UDI
FDA Product Code: IKD FDA UDI
GMDN Term: Electrocardiographic lead set, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.1175 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electrocardiographic lead set, reusable

MEDALink by Rising Eagle Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Electrocardiographic lead set, reusable.

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Unimed — Unimed Medical Supplies, Inc. · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II
ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
Unimed — Unimed Medical Supplies, Inc. · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Rising Eagle Medical

Sources (1)

FDA UDI 27ac665b-883e-464b-ab30-790ce0809bdb 34 fields · synced Jun 8, 2026