CTC004

Organization name

Cureety

SRN

FR-MF-000008930

Manufacturer status

Active

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

• CW010

  Communicated to HCPs: • The device is not intended to be used as a diagnostic tool, is not a substitute for existing medical practices, and is not a substitute for regular consultations and a conventional emergency medical management system as part of the patient's treatment. • Healthcare professionals should verify that the questions, questionnaires, and classification thresholds provided are appropriate for their practice and the patient's clinical condition. They may ask to modify these parameters to suit the patient and their own practice. • Healthcare professionals must be trained before using the device. • In order to monitor clinical signs and possible adverse events, professionals should consult both the notifications and the dashboard. • The device must be used with one of the following browsers: Google Chrome, Firefox, Safari and Edge. It should not be used with Internet Explorer, or any other browser, even if that browser is installed by default on your smartphone, tablet or computer. • The device may be temporarily unavailable during maintenance activities. • An Internet connection is required to use the device. • Browsers must be up to date. • Any serious incident occurring in connection with the use of the Cureety TechCare device should be reported to Cureety as well as to the relevant authorities in your country.
• CW011

  Communicated to Patients: Regardless of the application’s result, in case of severe symptoms or deterioration of your health condition, please consult a healthcare professional. The device is not intended to be used as a diagnostic tool, is not a substitute for existing medical practices, and is not a substitute for regular consultations and a conventional emergency medical management system as part of the patient's treatment. The device must be used with one of the following browsers: Google Chrome, Firefox, Safari and Edge. It should not be used with Internet Explorer, or any other browser, even if that browser is installed by default on your smartphone, tablet or computer. The device may be temporarily unavailable during maintenance activities. An Internet connection is required to use the device. The application must be updated regularly and used in its latest version. Browsers and operating systems must be up to date. Make sure you are using the latest version of the mobile application, available from Play Store and Apple Store. Any serious incident occurring in connection with the use of the Cureety TechCare device should be reported to Cureety as well as to the relevant authorities in your country.

Primary placement in France; available across 4 countries total.

Trade name

not provided

UDI-DI code

03770026852002

Basic UDI-DI

B-03770026852002

Reference / catalog number

CTC004

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Cureety TechCare is a software application intended to compute a clinical classification indicative of the clinical status of cancer patients, based on patient-reported symptoms and adverse events, in order to allow remote medical monitoring by healthcare professionals and facilitate follow-up care in both standard treatment settings and clinical trials, as a supplement to in-person consultations. Patients can self-monitor by reading informational messages related to their clinical status.

Additional information URL

https://www.cureety.com/wp-content/uploads/2024/07/Cureety_Manuel-d-utilisation-soignant.pdf

Clinical sizes

No clinical sizes registered for this device.

• Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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