gudid Primary ID: F2080

NA (UDI F2080)

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: F2080) 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: F2080
Product Code / EMDN: DRX
Device Name: Disposable ECG electrodes with solid gel, round-shaped 55mm, Silver/Silver Chloride(SSC) sensor and stainless steel snap. F2080 model is is made of non woven fabric. The fabric is made of plastic polyethylene fiber (and not natural fiber) that guarantees the transpiration of the skin, but at the same time the resistance to liquids with which they may come into contact during their use. F2080 is suitable for rest, long term, stress or Holter ECG recording, with a direct application onto the skin.
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 F2080.

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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