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DREAM System

by Ybia SAS France EUDAMED

Ref PP P4U One HS CModel DREAM System EMDN V92

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3770022767DREAMY4 Basic UDI-DIDate30 Jan 2025RegisteredStatusWithdrawn No longer placed on 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  • Withdrawn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European Union — CE/MDR Withdrawn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 · synced 25 Oct 2026

Model / Reference
DREAM System, PP P4U One HS C
Primary DI / UDI-DI
03770022767898
Basic UDI-DI
3770022767DREAMY4
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
Medical Purpose
DREAM is a virtual reality (VR) therapy software designed to help manage procedural pain and anxiety in pediatric patients during various medical procedures. It is a software that provides an immersive, non-pharmacological alternative or complementary solution to standard pharmacological treatments. By engaging patients in a calming and interactive VR environment, DREAM aims to distract and alleviate the perception of pain and/or anxiety associated with medical procedures.

Manufacturer details

EUDAMED SRN
FR-PR-000029204

Other devices from Ybia SAS

See all devices from Ybia SAS →

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 05e39639-a4ce-4b6a-b0fd-0a0fd8f9269a 61 fields · synced 25 Oct 2026