Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

12165 — Class I MDR by Coloplast A/S

MD Atlas
Coloplast A/S

EUDAMED last updated this device on Dec 1, 2025

12165

57089322975208K

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Coloplast A/S
UDI-DI code: 05701780795395
Reference / catalog number: 12165

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

Manufacturer information

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

Related devices

577657089322975158SOn the market 579157089322975158SOn the market 568757089322975158SOn the market 800557089322975158SOn the market 568757089322975158SOn 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.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Ireland; available across 2 countries total.

Country	On market since	Until
IrelandPrimary placement		Still on market
XI		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05701780795395
Basic UDI-DI: 57089322975208K
Reference / catalog number: 12165
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: Closed ostomy bag
Additional information URL: https://www.coloplast.com/
Clinical sizes: Flat
Base Plate Precut Start Hole Size — 30 MU50
Maxi

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05701780795395

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

Sign in to generate the UDI-PI DataMatrix

Create a free account, then generate the compliant UDI-PI carrier for this device.

Email

Password

No account yet?

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

A1001010102ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER
A1001020102ONE-PIECE ILEOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, 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

Become a partner of MD Atlas