CardioCare@Home Multi Lead Linear

EUDAMED

Class I (EU MDR)

Ref CardioCare@Home Multi Lead LinearModel CardioCare@Home

Identity

Trade Name: CardioCare@Home Multi Lead Linear EUDAMED
Model / Reference: CardioCare@Home EUDAMED
CardioCare@Home Multi Lead Linear EUDAMED

Device Class: Class I EUDAMED
Medical Purpose: CardioCare@Home is a prescription Procedure Pack that is intended to be used by a patient with suspected cardiac arrhythmias under strict supervision of a healthcare provider. CardioCare@Home bundles a number of medical devices and software accessories that are used as intended. Specifically, it includes a Byteflies Kit, compatible ECG electrodes, and the CardioCare@Home Pro software. 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 displayed by CardioCare@Home Pro in unmodified form to healthcare personnel for all enrolled patients in their care. Additionally, CardioCare@Home Pro can display event annotations generated elsewhere. CardioCare@Home does not extend or modify the intended use of the included components, it simply bundles them in a user-friendly package. Any diagnostic decisions made on data collected by CardioCare@Home are provided by a healthcare professional. EUDAMED

Sterile

EUDAMED

CardioCare@Home Multi Lead Linear 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	5430001718BF13000371LU	Class I	Active

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