eudamed_udi Primary ID: 05706069870619

HA EVK E-FM 50 CABRN (UDI 05706069870619)

Manufactured by Widex A/S

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

Scannable UDI-DI Representation

Device Regulatory Overview

The HA EVK E-FM 50 CABRN (Model/Catalog Number: 8 401 0160 071) is a medical device manufactured by Widex A/S. This product is indexed under FDA Product Code / Category Classification Y2145060101 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: 8 401 0160 071
Product Code / EMDN: Y2145060101
Device Name: BTE
Database Sync Date: 2026-08-09 16:28:56

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 HA EVK E-FM 50 CABRN?

The registered manufacturer of record for HA EVK E-FM 50 CABRN is Widex A/S.

What is the Primary UDI-DI identifier for HA EVK E-FM 50 CABRN?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05706069870619.

What classification code is assigned to this device?

This device is registered under product classification code Y2145060101.

Similar Classification Devices (Y2145060101)

Other Devices by Widex A/S

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