GUDIDData
gudid Primary ID: 11413

SenSura Mio (UDI 11413)

Manufactured by Coloplast A/S

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SenSura Mio - Primary ID 11413

Device Regulatory Overview

The SenSura Mio (Model/Catalog Number: 11413) is a medical device manufactured by Coloplast A/S. This product is indexed under FDA Product Code / Category Classification EXB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
11413
Product Code / EMDN
EXB
Device Name
Database Sync Date
2026-08-09 09:12:46

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 SenSura Mio?

The registered manufacturer of record for SenSura Mio is Coloplast A/S.

What is the Primary UDI-DI identifier for SenSura Mio?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 11413.

What classification code is assigned to this device?

This device is registered under product classification code EXB.

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