DA100-DASHBOARD

Nom de l'organisation

Ad Scientiam

SRN

FR-MF-000017145

Statut du fabricant

Actif

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

• CW030

  EUDAMED n'a pas publié de description pour ce code.
• CW010

  EUDAMED n'a pas publié de description pour ce code.

Marché principal en France ; disponible dans 1 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

03770027067016

Basic UDI-DI

3770027067SAMD0126

Numéro de référence/catalogue

DA100-DASHBOARD

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

MSCopilot is a software as a medical device consisting of a mobile application running on smartphones and a web portal. The mobile application is intended to be used by patients living with Multiple Sclerosis (MS) in their home environment, as an unsupervised self-assessment digital tool of various functional parameters. These parameters include walking perimeter, walking speed, hand function, low contrast visual acuity and cognitive processing time. The patient is not intended to take action on the device output without the consultation of a qualified Healthcare Professional (HCP). The assessment results are intended to be visualized on the web portal by healthcare professionals qualified to interpret the functional assessment results over time, for patient remote monitoring. MSCopilot is an adjunctive tool and is not intended to be used as a standalone diagnostic device nor to identify the presence or absence of clinical diagnoses. The healthcare professional benefit of MSCopilot is to track objective measures of key functional symptoms of the disease between consultations, supporting MS patients’ management. Another expected benefit is gain of healthcare time by providing a “big picture” of the patient's condition over time. Patients' clinical benefits rely on telemonitoring of functional tests analogous to modified Multiple Sclerosis Functional Composite, giving them access to a non-routinely clinical test that covers dimensions not taken into account with routine clinical tests (EDSS).

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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