GUDIDData
gudid Primary ID: GXR-82SD

DRGEM (UDI GXR-82SD)

Manufactured by DRGEM Corporation

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DRGEM - Primary ID GXR-82SD

Device Regulatory Overview

The DRGEM (Model/Catalog Number: GXR-82SD) is a medical device manufactured by DRGEM Corporation. This product is indexed under FDA Product Code / Category Classification MQB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
GXR-82SD
Product Code / EMDN
MQB
Device Name
400V3~ / 150kV
Database Sync Date
2026-08-09 09:26:40

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 DRGEM?

The registered manufacturer of record for DRGEM is DRGEM Corporation.

What is the Primary UDI-DI identifier for DRGEM?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is GXR-82SD.

What classification code is assigned to this device?

This device is registered under product classification code MQB.

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