GUDIDData
gudid Primary ID: M52645

Ponto (UDI M52645)

Manufactured by Oticon Medical AB

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Ponto - Primary ID M52645

Device Regulatory Overview

The Ponto (Model/Catalog Number: M52645) is a medical device manufactured by Oticon Medical AB. This product is indexed under FDA Product Code / Category Classification LXB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
M52645
Product Code / EMDN
LXB
Device Name
Ponto 3 Power, R, PUW
Database Sync Date
2026-08-09 09:12:44

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 Ponto?

The registered manufacturer of record for Ponto is Oticon Medical AB.

What is the Primary UDI-DI identifier for Ponto?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is M52645.

What classification code is assigned to this device?

This device is registered under product classification code LXB.

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