GUDIDData
eudamed_udi Primary ID: 06944413816589

Biofeedback and Stimulation System (UDI 06944413816589)

Manufactured by Edan Instruments,Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Biofeedback and Stimulation System - Primary ID 06944413816589

Device Regulatory Overview

The Biofeedback and Stimulation System (Model/Catalog Number: PR4 Pro) is a medical device manufactured by Edan Instruments,Inc.. This product is indexed under FDA Product Code / Category Classification U070399 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
PR4 Pro
Product Code / EMDN
U070399
Device Name
Biofeedback and Stimulation System
Database Sync Date
2026-08-09 16:29:16

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 Biofeedback and Stimulation System?

The registered manufacturer of record for Biofeedback and Stimulation System is Edan Instruments,Inc..

What is the Primary UDI-DI identifier for Biofeedback and Stimulation System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06944413816589.

What classification code is assigned to this device?

This device is registered under product classification code U070399.

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