Skip to content

DREAM + HypnoVR System

by Ybia SAS 20 variants

Ref PP HVR P4U One Q20i HS BModel DREAM + HypnoVR System

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3770022767DREAMHVRUF Basic UDI-DI 03760439350080UDI-DIDate30 Jan 2025RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Model / Reference
DREAM + HypnoVR System, PP HVR P4U One Q20i HS B
Primary DI / UDI-DI
03760439350080
Basic UDI-DI
3770022767DREAMHVRUF
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
Medical Purpose
DREAM is a virtual reality 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. HypnoVR is a virtual reality hypnosis solution intended to improve management of patients’ pain, stress and anxiety by providing an alternative or complementary solution to chemical treatments. HypnoVR is used with a virtual reality headset, an audio headset, and a tablet.

Manufacturer details

EUDAMED SRN
FR-PR-000029204

Other devices from Ybia SAS

See all devices from Ybia SAS →

Properties

Other properties (1)

  • Sterile: No