eudamed_udi Primary ID: 05706069686814

FPFP EVK E-IP R 110 CBRN (UDI 05706069686814)

Manufactured by Widex A/S

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

Scannable UDI-DI Representation

Device Regulatory Overview

The FPFP EVK E-IP R 110 CBRN (Model/Catalog Number: 8 405 0210 028) is a medical device manufactured by Widex A/S. This product is indexed under FDA Product Code / Category Classification Y2145060202 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: 8 405 0210 028
Product Code / EMDN: Y2145060202
Device Name: CUSTOM
Database Sync Date: 2026-08-09 16:30:29

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 FPFP EVK E-IP R 110 CBRN?

The registered manufacturer of record for FPFP EVK E-IP R 110 CBRN is Widex A/S.

What is the Primary UDI-DI identifier for FPFP EVK E-IP R 110 CBRN?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05706069686814.

What classification code is assigned to this device?

This device is registered under product classification code Y2145060202.

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