gudid Primary ID: ALLURE ARRD2

Widex (UDI ALLURE ARRD2)

Manufactured by Widex A/S

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Widex (Model/Catalog Number: ALLURE ARRD2) is a medical device manufactured by Widex A/S. This product is indexed under FDA Product Code / Category Classification OSM within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0094-2019 View Full Alert →

Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not lim...

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Technical Specifications

Model Number: ALLURE ARRD2
Product Code / EMDN: OSM
Device Name: HA ALLURE ARRD2 GBRN
Database Sync Date: 2026-08-09 09:12:36

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 Widex?

The registered manufacturer of record for Widex is Widex A/S.

What is the Primary UDI-DI identifier for Widex?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ALLURE ARRD2.

What classification code is assigned to this device?

This device is registered under product classification code OSM.

Similar Classification Devices (OSM)

Other Devices by Widex A/S

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