Skip to content

Pants Extra M

by Ontex BV Belgium EUDAMED

Ref EREF130221402, 130221402Model Heavy Inco

EMDN T04010103

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5414874HeavyIncoG5 Basic UDI-DIDate30 Apr 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Heavy Incontinence Devices
Model / Reference
Heavy Inco, EREF130221402, 130221402
Primary DI / UDI-DI
05411416073789, 05411416012771
Basic UDI-DI
5414874HeavyIncoG5
EMDN Code
T04010103 Incontinence nappies with integrated fixing system
Device Class
Class I
Market of Registration
France
Germany

Manufacturer details

EUDAMED SRN
BE-MF-000003544

Other devices from Ontex BV

See all devices from Ontex BV →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED fd59fb52-f69d-4a95-915c-2693f9018b44 61 fields · synced 22 Oct 2026
  • EUDAMED 05411416012771|5414874HEAVYINCOG5 61 fields · synced 18 May 2026