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Nexderma

by Arka, Europe, S.A. EUDAMED

Active European Union

Ref PH400Model Incontinence Nappies

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number560033446INCONTINENCETX Basic UDI-DIDate1 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Incontinence Nappies
Model / Reference
Incontinence Nappies, PH400
Primary DI / UDI-DI
05600334465183
Basic UDI-DI
560033446INCONTINENCETX
EMDN Code
T04010101 Rectangular incontinence nappies
Device Class
Class I
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
PT-MF-000004547

Other devices from Arka, Europe, S.A.

See all devices from Arka, Europe, S.A. →

Properties

Other properties (13)

  • Sterile: No
  • 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