GUDIDData
eudamed_udi Primary ID: 05701780931335

Assura (UDI 05701780931335)

Manufactured by Coloplast A/S

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Assura - Primary ID 05701780931335

Device Regulatory Overview

The Assura (Model/Catalog Number: 14234) is a medical device manufactured by Coloplast A/S. This product is indexed under FDA Product Code / Category Classification A1002010402 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
14234
Product Code / EMDN
A1002010402
Device Name
Assura/Alterna (Original) ostomy baseplate convex
Database Sync Date
2026-08-09 16:28:48

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 Assura?

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

What is the Primary UDI-DI identifier for Assura?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05701780931335.

What classification code is assigned to this device?

This device is registered under product classification code A1002010402.

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