DA100-IOS

Organization name

Ad Scientiam

SRN

FR-MF-000017145

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW030

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 1 country total.

Trade name

not provided

UDI-DI code

03770027067023

Basic UDI-DI

3770027067SAMD0126

Reference / catalog number

DA100-IOS

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

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).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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