HypnoVR System
Ref HVR-G3-M9-Q20i-B, HypnoVR V1.13, HVR-P4U-M9-E500-R, HVR-P4U-One-E500-R, HVR-P4U-One-E500-C, HypnoVR V1.11, HypnoVR Dental System, HVR P4U Q20i HS C, HVR P4U HS B, HVR-P4U-One-Q20i-R, HypnoVR System, HVR-P4U-One-Q20i-C, HVR-P4U-M9-E500-B, HVR-G3-One-E500-R, HVR-G3-One-E500-B, HVR-P4U-M9-Q20i-C, HVR-P4U-M9-Q20i-R, HVR-P4U-One-E500-BModel HypnoVR
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3770022767HypnoVRSNG | Date11 Oct 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- HypnoVR SystemHypnoVR
- Model / Reference
- HVR-G3-M9-Q20i-B, HypnoVR, HypnoVR V1.13, HVR-P4U-M9-E500-R, HVR-P4U-One-E500-R, HVR-P4U-One-E500-C, HypnoVR V1.11, HypnoVR Dental System, HVR P4U Q20i HS C, HVR P4U HS B, HVR-P4U-One-Q20i-R, HypnoVR System, HVR-P4U-One-Q20i-C, HVR-P4U-M9-E500-B, HVR-G3-One-E500-R, HVR-G3-One-E500-B, HVR-P4U-M9-Q20i-C, HVR-P4U-M9-Q20i-R, HVR-P4U-One-E500-B
- Primary DI / UDI-DI
- 03770022767904, 03770022767096, 03760439350103, 03760439350127, 03770022767713, 03770022767041, 03770022767324, 03770022767973, 03770022767560, 03760439350134, 03770022767164, 03770022767072, 03770022767997, 03770022767553, 03770022767690, 03770022767683, 03770022767959, 03760439350110, 03770022767706, 03770022767225, 03770022767232, 03770022767188, 03770022767171, 03770022767386, 03770022767393, 03770022767256
- Basic UDI-DI
- 3770022767HypnoVRSNG, 3770022767HypnoVRS6
- Direct Marketing DI
- 0377002276709603770022767041
- EMDN Code
- V92 Medical device software - not included in other classes
- Device Class
- Class I
- Special Device Type
- Software
- EU market of registration
- France
- Medical Purpose
- 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
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