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DREAM System

by Ybia SAS 4 variants

Ref PP P4U HS C, PP-P4U-One-E500-C, PP P4U HS B, PP-P4U-One-E500-R, PP P4U One HS B, PP-P4U-M9-E500-B, PP-P4U-One-E500-B, PP-P4U-M9-E500-CModel DREAM System

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3770022767DREAMY4 Basic UDI-DI Date30 Jan 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
DREAM System, PP P4U HS C, PP-P4U-One-E500-C, PP P4U HS B, PP-P4U-One-E500-R, PP P4U One HS B, PP-P4U-M9-E500-B, PP-P4U-One-E500-B, PP-P4U-M9-E500-C
Primary DI / UDI-DI
03770022767539, 03770022767874, 03770022767676, 03760439350196, 03770022767881, 03770022767669, 03770022767867, 03770022767454
Basic UDI-DI
3770022767DREAMY4
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
Medical Purpose
DREAM is a virtual reality (VR) 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.

Manufacturer details

EUDAMED SRN
FR-PR-000029204

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Properties

Other properties (1)

  • Sterile: No