Vs-4

EUDAMED

Class I (EU MDR)

Ref VS-4Model Vital Signs

Identity

Device Class: Class I EUDAMED
Medical Purpose: Vital Signs is a prescription Procedure Pack intended to be used by a patient whose vital signs (like weight, blood pressure, oxygen saturation, ...) are measured under strict supervision of a health care provider Vital Signs bundles the following medical devices and medical device accessories: Medical Device: Byteflies kit with or without Sensor Dots (manufactured by Byteflies) Medical Device: Byteflies ECG adhesives or compatible 3rd party electrodes that allow ECG measurements (optional, depends on variant) Accessory to Byteflies Kit: Byteflies 4-wire cradle, 4-snap Cradle, 3-snap left cradle, 3-snap right cradle, 2-snap cradle, 3-snap cradle, and Double Sided Adhesives (optional, depends on variant) Medical Device: Byteflies EEG adhesives or compatible 3rd party electrodes that allow behind-the-ear EEG measurements (optional, depends on variant) Vital Signs Measure devices (Digital weight scale, Blood Pressure Monitor, SPO2 Monitor, Thermometer) Mobile Wifi router with simcard (CE certified) IFU: Patient Guide Medical Device (SaMD): [Vital Signs Pro] (optional, depends on variant) These devices were demonstrated to be interoperable. Vital Signs also bundles the following services which are not regulated by EU MDR 2017/745: Logistical services to ensure procedure packs are delivered to the right user at the right time. EUDAMED

Sterile

EUDAMED

Vs-4 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	5430001718BF13000545M5	Class I	Active

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