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EasiCath

by Coloplast A/S 93 variants

Ref 5354

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  • Withdrawn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
5354
Primary DI / UDI-DI
05701780489911, 05701780928380, 05701780028554, 05701780878005, 05701780215497, 05701780922111, 05701780036467, 05701780944403, 05708932392884, 05701780388818, 05701780416122, 05701780028363, 05708932494168, 05701780028745, 05701780892247, 05701780842624
Basic UDI-DI
57089322978169B
Unit of Use DI
05701780187169, 05701780429511, 05701780187244, 05701780187299, 05701780187329, 05701780429252, 05708932965422, 05701780429177, 05708932784054, 05701780187206, 05701780187213, 05701780187138, 05701780429207, 05701780187145, 05701780429238, 05708932197830
EMDN Code
U01010501 Nelaton catheters, self-lubricating
Device Class
Class I
EU market of registration
Denmark
Belgium
Norway
Czechia
Ireland
Croatia
Germany
Portugal
Romania
Finland
Greece
Italy
Lithuania
Netherlands
Slovenia
Spain

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