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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Assura/Alterna (New Generation) ostomy… — 221 UDI-DI variants, MDR

MD Atlas
Coloplast A/S

Data from EUDAMED, last updated May 31, 2026

Assura/Alterna (New Generation) ostomy bag 1-piece closed

57089322975208K

221 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: Coloplast A/S

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 57089322975208K
Device name: Assura/Alterna (New Generation) ostomy bag 1-piece closed
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Dec 1, 2025

Manufacturer & authorised representative

Manufacturer

Name: Coloplast A/S
SRN: DK-MF-000025526
Country: Denmark
Email: Eudamed_PA_Contact@coloplast.com
Phone: +4549111111

Variants by status

UDI-DI variants

221 UDI-DI variants

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Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

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