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DREAM + HypnoVR Biofeedback System

by Ybia SAS 9 variants

Ref PP HVRBIO P4U One HS BModel DREAM + HypnoVR Biofeedback 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Withdrawn Withdrawn in European Union.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Was authorized under CE MDR, withdrawn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Withdrawn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 linked in EUDAMED

A group certificate may exist

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 Number3770022767DREAMHVRBIO4A Basic UDI-DI 03770022767843UDI-DIDate30 Jan 2025RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Model / Reference
DREAM + HypnoVR Biofeedback System, PP HVRBIO P4U One HS B
Primary DI / UDI-DI
03770022767843
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

Other properties (1)

  • Sterile: No