Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ 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

21564 — Class I MDR by Coloplast A/S

MD Atlas
Coloplast A/S

EUDAMED last updated this device on Apr 2, 2026

21564

57089322978819N

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Coloplast A/S
UDI-DI code: 05701780193924
Reference / catalog number: 21564

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?

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 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: 05701780193924
Basic UDI-DI: 57089322978819N
Reference / catalog number: 21564
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: 1
Additional product description: Urine collection bag
Additional information URL: https://www.coloplast.com/
Clinical sizes: 350 MU48
Inlet Tube Length — 25 MU10

EMDN nomenclature code(s)

A06030301URINE COLLECTION BAGS

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