gudid Primary ID: 5 x Low, 5 x Elevated

Control Samples US (UDI 5 x Low, 5 x Elevated)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Control Samples US (Model/Catalog Number: 5 x Low, 5 x Elevated) is a medical device manufactured by M DIALYSIS INC.. This product is indexed under FDA Product Code / Category Classification GWM within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 5 x Low, 5 x Elevated
Product Code / EMDN: GWM
Device Name
Database Sync Date: 2026-08-09 09:10:27

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 Control Samples US?

The registered manufacturer of record for Control Samples US is M DIALYSIS INC..

What is the Primary UDI-DI identifier for Control Samples US?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5 x Low, 5 x Elevated.

What classification code is assigned to this device?

This device is registered under product classification code GWM.

Similar Classification Devices (GWM)

Other Devices by M DIALYSIS INC.

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