GUDIDData
gudid Primary ID: Focus

Focus (UDI Focus)

Manufactured by PaloDEx Group Oy

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

Device Regulatory Overview

The Focus (Model/Catalog Number: Focus) is a medical device manufactured by PaloDEx Group Oy. This product is indexed under FDA Product Code / Category Classification JXE within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
Focus
Product Code / EMDN
JXE
Device Name
2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from thehuman nervous and muscular systems in a clinical environment. The system enables the healthcare provider to perform evoked potentials, nerve conductions and needle EMG studies as an aid in the evaluation of patients with central and peripheral nervous system symptoms.
Database Sync Date
2026-08-09 09:15:32

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 Focus?

The registered manufacturer of record for Focus is PaloDEx Group Oy.

What is the Primary UDI-DI identifier for Focus?

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

What classification code is assigned to this device?

This device is registered under product classification code JXE.

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