eudamed_udi Primary ID: 07613389814491

AudioNova S5-10 O (UDI 07613389814491)

Manufactured by Sonova AG

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

Scannable UDI-DI Representation

Device Regulatory Overview

The AudioNova S5-10 O (Model/Catalog Number: 063-6399-0165) is a medical device manufactured by Sonova AG. This product is indexed under FDA Product Code / Category Classification Y2145060201 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 063-6399-0165
Product Code / EMDN: Y2145060201
Device Name: Sonova ITE hearing aids
Database Sync Date: 2026-08-09 16:29:16

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 AudioNova S5-10 O?

The registered manufacturer of record for AudioNova S5-10 O is Sonova AG.

What is the Primary UDI-DI identifier for AudioNova S5-10 O?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 07613389814491.

What classification code is assigned to this device?

This device is registered under product classification code Y2145060201.

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