Skip to content

EasiCath

by Coloplast A/S 93 variants

Ref 5370

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  • Withdrawn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
5370
Primary DI / UDI-DI
05701780036399, 05701780028592, 05701780842846, 05701780215534, 05701780951333, 05701780878241, 05701780489997, 05701780950831, 05701780895798, 05701780028400, 05701780388856, 05708932392945, 05701780448215, 05701780956130, 05701780928540, 05701780748407, 05701780512268
Basic UDI-DI
57089322978169B
Unit of Use DI
05708932965361, 05701780188210, 05708932196956, 05701780188364, 05701780427272, 05701780188234, 05701780188388, 05701780188425, 05701780427265, 05701780188289, 05701780188326, 05701780427258, 05701780188333, 05701780427227, 05701780188449, 05701780427241, 05701780188296
EMDN Code
U01010501 Nelaton catheters, self-lubricating
Device Class
Class I
EU market of registration
Germany
Norway
Spain
Ireland
Croatia
Czechia
Denmark
Netherlands
Slovenia
Italy
Finland
Romania
Liechtenstein
Portugal
Belgium
Hungary
Greece

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