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DREAM + HypnoVR Biofeedback System

by Ybia SAS EUDAMED

Withdrawn No longer placed on the EU market

Ref PP HVRBIO P4U One BModel DREAM + HypnoVR Biofeedback System

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3770022767DREAMHVRBIO4A 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  • Withdrawn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European Union — CE/MDR Withdrawn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

Model / Reference
DREAM + HypnoVR Biofeedback System, PP HVRBIO P4U One B
Primary DI / UDI-DI
03770022767829
Basic UDI-DI
3770022767DREAMHVRBIO4A
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
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 Biofeedback is a virtual reality hypnosis solution with or without biofeedback intended to improve management of patients’ pain, stress and anxiety by providing an alternative or complementary solution to chemical treatments. HypnoVR Biofeedback is used with a virtual reality headset, an audio headset, and a tablet.

Manufacturer details

EUDAMED SRN
FR-PR-000029204

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Properties

Show properties
Other properties (1)
  • Sterile: No