gudid Primary ID: 058-5268-0510

Unitron TrueFit 5.10 USB (UDI 058-5268-0510)

Manufactured by Sonova AG

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Unitron TrueFit 5.10 USB (Model/Catalog Number: 058-5268-0510) is a medical device manufactured by Sonova AG. This product is indexed under FDA Product Code / Category Classification OSM within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 058-5268-0510
Product Code / EMDN: OSM
Device Name
Database Sync Date: 2026-08-09 09:19:56

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 Unitron TrueFit 5.10 USB?

The registered manufacturer of record for Unitron TrueFit 5.10 USB is Sonova AG.

What is the Primary UDI-DI identifier for Unitron TrueFit 5.10 USB?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 058-5268-0510.

What classification code is assigned to this device?

This device is registered under product classification code OSM.

Similar Classification Devices (OSM)

Other Devices by Sonova AG

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