GUDIDData
eudamed_udi Primary ID: 05714464115242

Oticon (UDI 05714464115242)

Manufactured by SBO Hearing A/S

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Oticon - Primary ID 05714464115242

Device Regulatory Overview

The Oticon (Model/Catalog Number: 238008) is a medical device manufactured by SBO Hearing A/S. This product is indexed under FDA Product Code / Category Classification Y2145060102 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
238008
Product Code / EMDN
Y2145060102
Device Name
HI (BTE)
Database Sync Date
2026-08-09 16:28:45

Full Regulatory Attributes

🔒 Token Gated
{
    "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 Oticon?

The registered manufacturer of record for Oticon is SBO Hearing A/S.

What is the Primary UDI-DI identifier for Oticon?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05714464115242.

What classification code is assigned to this device?

This device is registered under product classification code Y2145060102.

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