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

PA5035 — Class I MDR by Coloplast A/S

MD Atlas
Coloplast A/S

EUDAMED last updated this device on Apr 20, 2026

PA5035

57089322978419A

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Coloplast A/S
UDI-DI code: 03600040251577
Reference / catalog number: PA5035

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

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 France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03600040251577
Basic UDI-DI: 57089322978419A
Reference / catalog number: PA5035
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: Urisheath
Additional information URL: https://www.coloplast.com/
Clinical sizes: 35 MU50

EMDN nomenclature code(s)

U070201SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE

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

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.