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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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Organization name
UDI-DI code
Reference / catalog number

13946 — Class I MDR by Coloplast A/S

MD Atlas
Coloplast A/S

EUDAMED last updated this device on Dec 12, 2025

13946

57089322975508U

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Coloplast A/S
UDI-DI code: 05701780827188
Reference / catalog number: 13946

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Manufacturer information

Organization name: Coloplast A/S
SRN: DK-MF-000025526
Manufacturer status: Active

Related devices

1426157089322976108MOn the market 1397557089322975508UOn the market 1398457089322975508UOn the market 1398557089322975508UOn the market 1398657089322975508UOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW025
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05701780827188
Basic UDI-DI: 57089322975508U
Reference / catalog number: 13946
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 30
Additional product description: Open ostomy bag
Additional information URL: https://www.coloplast.com/
Clinical sizes: Midi
Coupling Size Diameter — 60 MU50

EMDN nomenclature code(s)

A10020302ILEOSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER
A10020202COLOSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification