Brisa

Organization name

Temedica GmbH

SRN

DE-MF-000006165

Manufacturer status

Active

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

• CW011

  Never use tracked data for self-diagnosis or self therapy. Always consult an appropriate one first healthcare professional to interpret the recorded data and further coordination of the diagnosis or Therapy. Don't let the software compete with you Never tempt yourself and engage in activity more than is appropriate for yours body feels good. Should you feel that your symptoms through activities triggered by the software deteriorate, contact the person named in confidence Customer Service or consult a healthcare professional directly in healthcare before doing the activities stimulated by the app, further use.
• CW010

  Includes relevant notices and cautions for proper use

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04260592190015

Basic UDI-DI

06059219GMN00195

Reference / catalog number

Brisa

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

Brisa is a personal digital companion for people with MS to get informed about their disease, organize their life with MS and collect data in order to track their personal MS course and share the information with the treating physician(s). The product includes following clinical claim functions: - Medical Questionaires: The user wants a section where he or she can fill out various validated medical questionnaires like MFIS5- 5 questions, BDI-FS- 7 questions, PDQ-5 questions, BLCS (Bladder Control Scale)- 4 questions, BWCS (Bowel Control Scale)- 5 questions, SSS (Sexual Satisfaction Scale) - 4 questions and PDDS(Patient Determined Disease Steps)- 1 question. Entering this data helps him to get a better picture of his personal disease development and he can provide his doctor with better information. - Symptom Tracking At regular intervals, the user is interviewed about relevant user-reported data from the field of MS, such as Fatigue, Depression, Cognition, Bladder Dysfunction, Bowel Disorder, Sexual Dysfunction and Disability. These data help the user to follow his own disease progression and provide better information to his doctor. - Data Sharing with HCPs: In order to inform his attending HCP about the course of the disease, the user should be able to share the disease data he has entered with his HCP. For this purpose, there should be a function that allows the health data to be made available to the doctor in a simple manner. There will be various export functions such as email, PDF for printing or a special dashboard where the doctor can view the user's data. The Produkt includes additional non-clinical functions: Personalization & Customization, Motivation & Gamification, Reports & Data Graphs, Situated Data and OcreButler/Therapy Preparation.

Additional information URL

https://www.brisa-app.de/

Clinical sizes

No clinical sizes registered for this device.

• Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

This device is not currently linked to any other device.