gudid Primary ID: F9049

NA (UDI F9049)

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: F9049) 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: F9049
Product Code / EMDN: DRX
Device Name: Disposable ECG electrodes, oval-shaped 48x34mm dimensions with solid gel, Silver/Silver Chloride (SSC) sensor and stainless steel snap. F9049 model is suitable for rest, long term, stress or Holter ECG recording, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording. The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids.
Database Sync Date: 2026-08-09 09:04:39

Full Regulatory Attributes

🔒 Token Gated

{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

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 F9049.

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

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint