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RiSolve

by Amara Therapeutics Ltd. Ireland EUDAMED

Ref PDTxA001Model OABPDTX

EMDN V92

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number539154538OABPDTXQD Basic UDI-DIDate11 Dec 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
RiSolve App
Model / Reference
OABPDTX, PDTxA001
Primary DI / UDI-DI
05391545380005
Basic UDI-DI
539154538OABPDTXQD
Direct Marketing DI
05391545380005
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
Special Device Type
Software
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000045497

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 bf15d9ae-f91b-4378-a9de-c41e8d989854 61 fields · synced 22 Oct 2026