SenopiMed

Dénomination commerciale

SenopiMed

Code d'IUD-ID

07649990898018

IUD-ID de base

7649990898SenopiMedYZ

Numéro de référence/catalogue

SenopiMed

Entité d'attribution

GS1

Catégorie de risque

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

SenopiMed is an active medical device intended for the prevention and alleviation of physical debility and/or cognitive decline in seniors with age-related physical debility (R54) and/or mild cognitive impairment (G31.84) or who are at increased risk thereof by providing physical and cognitive training which is delivered through a VR headset. The training session may be accompanied by a healthcare professional while the senior is in a clinical setting. The device displays the completion of a programme to both the user (senior) and the healthcare professional but does not give any indication of the user’s performance. Therefore, the device output is of no clinical significance and cannot be used for monitoring purposes and/or clinical decision-making.

URL des informations complémentaires

https://www.senopi.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• N010299NEUROLOGIC PHYSIOTHERAPHY DEVICES - OTHER

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW011

  SenopiMed should not get in contact with liquids with liquids, SenopiMed VR headset should not get in touch with fire or warm surfaces, SenopiMed VR headset’s lenses should not be exposed to direct sunlight, Do not use it when is connected to the charger/when is charging.

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.

Ce dispositif n'est actuellement lié à aucun autre dispositif.