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alea Software

by AssistMe GmbH Germany EUDAMED

Ref AL00017

EMDN T99

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42557126ASSISTMEALEA5E Basic UDI-DIDate23 Apr 2025RegisteredStatusActive

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
alea - AssistMe Digital Assistance System
Model / Reference
AL00017
Primary DI / UDI-DI
04255712600031
Basic UDI-DI
42557126ASSISTMEALEA5E
Direct Marketing DI
04255712600031
EMDN Code
T99 Protective devices and aids for incontinence (excluding personal protective equipment - PPE) - other
Device Class
Class I
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000039002

Other devices from AssistMe GmbH

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 (1)

  • EUDAMED bca3f15e-d543-4244-81b2-eef0640278d0 61 fields · synced 22 Oct 2026