Smart Care Plans

Nom de l'organisation

Platform24 Healthcare AB

SRN

SE-MF-000026278

Statut du fabricant

Actif

5 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW999

  Patients with life-threatening symptoms that require immediate medical attention, i.e. are expected to need acute hospitalization within 24 hours. In cases where these symptoms are discovered during the use of Smart Care Plans, the use of the device shall stop.
• CW999

  Patients who are not well-informed about their health condition, including but not limited to, recognizing signs of deterioration of their health condition and knowing when, where and how to seek emergency care if needed.
• CW999

  Patients with severe cognitive issues (including but not limited to dementia or severe intellectual disability)
• CW999

  Patients for which access to the required medical data for use of a smart digital care plan is restricted
• CW999

  Smart Care Plans is not intended to provide information which is used to take decisions with diagnosis or therapeutic purposes where such decisions have an impact that may cause death, irreversible deterioration of a person's state of health, serious deterioration of a person's state of health or a surgical intervention.

Marché principal en Suède ; disponible dans 3 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

07350127221011

Basic UDI-DI

735012722P24002LT

Numéro de référence/catalogue

Smart Care Plans

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

URL des informations complémentaires

https://platform24.com/manuals

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

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

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Santé des certificats sur le portefeuille de ce fabricant.