gudid Primary ID: F2017H

NA (UDI F2017H)

Manufactured by FIAB SPA

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

Scannable UDI-DI Representation

Device Regulatory Overview

The NA (Model/Catalog Number: F2017H) is a medical device manufactured by FIAB SPA. This product is indexed under FDA Product Code / Category Classification DRX within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: F2017H
Product Code / EMDN: DRX
Device Name: Disposable round-shaped ECG electrodes with liquid gel, 60mm, Silver/Silver Chloride(SSC) sensor and metal snap. These electrodes are suitable for short and medium term monitoring, stress ECG recording and Holter, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording and off-centered configuration allows a better quality of ECG signal and reduces artifacts.
Database Sync Date: 2026-08-09 09:04:31

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 NA?

The registered manufacturer of record for NA is FIAB SPA.

What is the Primary UDI-DI identifier for NA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is F2017H.

What classification code is assigned to this device?

This device is registered under product classification code DRX.

Similar Classification Devices (DRX)

Other Devices by FIAB SPA

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