eudamed_udi Primary ID: 05706069844511

ENJOY Z E-FS-T 440 (UDI 05706069844511)

Manufactured by Widex A/S

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

Scannable UDI-DI Representation

Device Regulatory Overview

The ENJOY Z E-FS-T 440 (Model/Catalog Number: 10973549) is a medical device manufactured by Widex A/S. This product is indexed under FDA Product Code / Category Classification Y2145060102 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: 10973549
Product Code / EMDN: Y2145060102
Device Name: RIC
Database Sync Date: 2026-08-09 16:28:53

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 ENJOY Z E-FS-T 440?

The registered manufacturer of record for ENJOY Z E-FS-T 440 is Widex A/S.

What is the Primary UDI-DI identifier for ENJOY Z E-FS-T 440?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05706069844511.

What classification code is assigned to this device?

This device is registered under product classification code Y2145060102.

Similar Classification Devices (Y2145060102)

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