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PressureAI

by Prelego Holdings Ltd EUDAMED

Withdrawn Not intended for the EU market

Ref PAI-001Model PressureAI

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50700046PAI016T Basic UDI-DIDate9 Apr 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
PressureAI Hospital-Acquired Pressure Ulcer Risk Prediction System
Model / Reference
PressureAI, PAI-001
Primary DI / UDI-DI
05070004609313
Basic UDI-DI
50700046PAI016T
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
Software

Manufacturer details

EUDAMED SRN
UK-MF-000053065
Authorised representative
BEO MedConsulting Berlin GmbH DE-AR-000006764

Properties

Show 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