DREAM + HypnoVR System
by Ybia SAS France EUDAMED
Ref PPHVR-P4U-One-E500-RModel DREAM + HypnoVR System EMDN V92
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3770022767DREAMHVRUF | Date30 Jan 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- DREAM + HypnoVR System, PPHVR-P4U-One-E500-R
- Primary DI / UDI-DI
- 03760439350165
- 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
Properties & raw data
Show properties, registry sources and raw records
Other properties (1)
- Sterile: No
Sources (1)
- EUDAMED 54c97cbe-07b4-4c24-a4b2-27da22aa8f4c