Healthentia v4

Nom de l'organisation

INNOVATION SPRINT SRL

SRN

BE-MF-000000879

Statut du fabricant

Actif

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

• CW999

  CONTRA-INDICATIONS: • Healthentia is not intended for the monitoring of patients in critical situations (operating room, emergency, intensive care). • Any physical or cognitive condition that, in clinical judgment, would prevent the patient from using Healthentia, e.g. dementia. • The device should not be used during pregnancy. • Healthentia has not been tested with pediatric population. Therefore, Healthentia is intended for adult use only (>18 years old) and does not cover use by children. • The device is not intended to replace the care of a health care professional, including prescription, diagnosis or treatment. • Consult periodically the Alerts dashboard as it may influence the follow-up of your patients. • The user is responsible of the final assessment of the diagnosis and treatment decided for the patient. • The device providing information to support diagnostic and therapeutic decision, but the overall clinical context should be taken into consideration before taking any decision.
• CW999

  WARNINGS: • The device is not intended to replace the care of a health care professional, including prescription, diagnosis or treatment. • Consult periodically the Alerts dashboard as it may influence the follow-up of your patients. • Healthentia is not monitored in real time by healthcare personnel; it is intended for non-emergency communication only. In case of an emergency, contact your care unit or the emergency number by phone. • In some special cases, the self-care advice and instructions provided by Healthentia may not be applicable to your situation. • If you have questions about your care, symptoms and management, contact your healthcare team. • The device is not intended to replace the care of a healthcare professional, including prescription, diagnosis or treatment. • Telemonitoring does not replace regular check-ups with your doctor. Consult your doctor in case of severe and persistent symptoms. • In combination with Healthentia, use only measuring devices for which the technical performances (accuracy, precision) have been verified by your healthcare provider as it may affect the outcome of your monitoring. • Verify the consistency of your clinical data and the good transfer of them to your healthcare provider as the quality of the diagnosis and treatment is partially based on this information.
• CW999

  DISCLAIMER: • The user is responsible of the final assessment of the diagnosis and treatment decided for the patient. • The device providing information to support diagnostic and therapeutic decision, but the overall clinical context should be taken into consideration before taking any decision. • Your healthcare provider is responsible of the final assessment of your diagnosis and treatment. • Healthentia is providing information to support diagnostic and therapeutic decision, but the overall clinical context should be taken into consideration before taking any decision.

Marché principal en Belgique ; disponible dans 12 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

05419980178930

Basic UDI-DI

54199801789HLTv4GY

Numéro de référence/catalogue

Healthentia v4

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

—

URL des informations complémentaires

https://healthentia.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Ce dispositif n'est actuellement lié à aucun autre dispositif.

Santé des certificats sur le portefeuille de ce fabricant.