Aucun dispositif spécifique n'est listé pour ce certificat.
Caractéristiques
Stérile
Non
Tissus humains
Non
Tissus animaux
Non
Diagnostic in vitro
Non
Enregistrement initial
Oui
Dispositif nouveau
Non
Élimination autorisée
Non
RSCP activé
Oui
Mécanisme de contrôle
Oui
Destination médicale
Non
RSCP applicable
Non
Conditions applicables
Non
MOS hors EUDAMED
—
Type SMQ/MOS
Classe IIb uniquement
Historique
Aucun changement de statut ni certificat précédent enregistré.
Périmètre de couverture
Classe IIb2
2 périmètres
Digistat Care (hereafter “Product”)
is a software that transfers, stores,
elaborates, aggregates, organizes
and displays patient information
and patient related data, including
data and events from medical
devices and systems as well as
information entered manually, in
order to drive clinical management
providing information to: - Support
treatment, diagnoses, prevention,
monitoring, prediction, prognosis
and mitigation of disease; - Triage
or identify early signs of disease or
conditions.