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EasiCath

by Coloplast A/S 93 variants

Ref 5352

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57089322978169B Basic UDI-DI Date22 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
EasiCath urinary intermittent drainage catheter
Model / Reference
5352
Primary DI / UDI-DI
05701780489898, 05701780891264, 05701780028356, 05701780416108, 05701780028738, 05701780388801, 05701780036450, 05708932147828, 05708932392860, 05701780842600, 05701780957175, 05701780928366, 05701780215480, 05701780922135, 05708932494144, 05701780877985
Basic UDI-DI
57089322978169B
Unit of Use DI
05701780187022, 05701780428859, 05701780187008, 05701780187077, 05701780187015, 05701780187039, 05708932965439, 05701780428729, 05701780428835, 05708932197847, 05701780428743, 05701780429078, 05701780186995, 05701780428873, 05701780428811, 05701780186988
EMDN Code
U01010501 Nelaton catheters, self-lubricating
Device Class
Class I
EU market of registration
Denmark
Slovenia
Italy
Greece
Netherlands
Finland
Germany
Hungary
Romania
Spain
Portugal
Belgium
Ireland
Croatia
Lithuania
Czechia

Manufacturer details

EUDAMED SRN
DK-MF-000025526

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No