EpiCare Focal Left

EUDAMED

Class I (EU MDR)

Ref EpiCare Focal LeftModel EpiCare@Home

Identity

Device Class: Class I EUDAMED
Medical Purpose: EpiCare@Home is a prescription Procedure Pack that is intended to be used by a patient with epilepsy under strict supervision of a healthcare provider. EpiCare@Home bundles a number of medical devices and software accessories that are used as intended. Specifically, it includes a Byteflies Kit, compatible EEG and (optionally) ECG electrodes, and the EpiCare@Home UI software. In addition, it includes the EpiCare@Home Assistant mobile app, which is not a medical device or accessory. Byteflies Kit is used to record and transmit relevant physiologic and behavioral data from the patient's home to the hospital or other healthcare provider. The recorded data is organized by the EpiCare@Home UI software and made available to healthcare personnel for all enrolled patients in their care. In addition, the EpiCare@Home Assistant app can guide the patient in how to use EpiCare@Home, communicate with technical support, and submit patient-reported information on symptoms. EpiCare@Home does not extend or modify the intended use of the included medical devices, it simply bundles them in a user-friendly package. Any diagnostic decisions made on data collected by EpiCare@Home are provided by a healthcare professional. EUDAMED

Sterile

EUDAMED

EpiCare Focal Left by Byteflies NV — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	5430001718BF13000357M2	Class I	Active

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