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HypnoVR Biofeedback System

by Ybia SAS France EUDAMED

Ref HVRBIO P4U One HS B EMDN V92

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3770022767HBiofeedbackSUE Basic UDI-DIDate2 Feb 2024RegisteredStatusWithdrawn 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  • Withdrawn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European Union — CE/MDR Withdrawn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 24 Oct 2026

Model / Reference
HVRBIO P4U One HS B
Primary DI / UDI-DI
03770022767768
Basic UDI-DI
3770022767HBiofeedbackSUE
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Medical Purpose
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, a tablet and a sensor.

Manufacturer details

EUDAMED SRN
FR-PR-000029204

Other devices from Ybia SAS

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Properties & raw data

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

Sources (1)

  • EUDAMED 0398950c-b856-4fbf-ad64-647ab3dc5112 61 fields · synced 24 Oct 2026