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HypnoVR Biofeedback System

by Ybia SAS 5 variants

Ref HVRBIO P4U HS C, HypnoVR Biofeedback system - ANI Guardian, HypnoVR Biofeedback V3.X.Y, HVRBIO P4U One HS C, HVRBIO P4U One B, HVRBIO P4U C, HypnoVR Biofeedback V1.X.X'Model HypnoVR Biofeedback

Withdrawn Withdrawn in European Union.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Was authorized under CE MDR, withdrawn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Withdrawn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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3770022767HBiofeedbackSUE Basic UDI-DI Date2 Feb 2024RegisteredStatusWithdrawn 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  • Withdrawn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European Union — CE/MDR Withdrawn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

Trade Name
HypnoVR Biofeedback System
HypnoVR Biofeedback
Model / Reference
HVRBIO P4U HS C, HypnoVR Biofeedback system - ANI Guardian, HypnoVR Biofeedback, HypnoVR Biofeedback V3.X.Y, HVRBIO P4U One HS C, HVRBIO P4U One B, HVRBIO P4U C, HypnoVR Biofeedback V1.X.X'
Primary DI / UDI-DI
03770022767508, 03770022767201, 03770022767287, 03770022767775, 03770022767744, 03770022767447, 03770022767010
Basic UDI-DI
3770022767HBiofeedbackSUE, 3770022767HBiofeedbackYV
Direct Marketing DI
03770022767287
03770022767010
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
Software
EU market of registration
France
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

See all devices from Ybia SAS →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No