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Vs-7

EUDAMED

Class I (EU MDR)

Ref 05430001718454Ref VS-7Model Vital Signs

by Byteflies NV

Identity

Trade Name
VS-7 EUDAMED
Device Name
Vital Signs EUDAMED
Model / Reference
05430001718454 EUDAMED
Vital Signs EUDAMED
VS-7 EUDAMED

Identifiers

Primary DI / UDI-DI
05430001718454 EUDAMED
Basic UDI-DI
5430001718BF13000545M5 EUDAMED
EMDN Code
Z12030299 VITAL SIGNS MONITORING INSTRUMENTS - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Medical Purpose
Vital Signs is a prescription Procedure Pack that is intended to remote monitor a patient whose vital signs should be sent to a supervising healthcare professional. Vital Signs bundles a number of medical devices and accessories that are used as intended. Specifically, the main components are a Byteflies Kit Model 2, vital sign and health parameter measuring devices (such as body weight scale, blood pressure cuff, body thermometer, and oxygen saturation monitor), a wifi router, compatible ECG and EEG electrodes, and Vital Signs Pro software. The Byteflies Kit Model 2 is used to transmit the measured vital signs and health parameters from the patient's home to the hospital or other healthcare provider. The data can be imported into, and visualized in compatible medical record systems. The recorded data can be organized by the Vital Signs Pro software and made available to the healthcare professional for all enrolled patients in their care. Vital Signs does not extend or modify the intended use of the included components, it simply bundles them in a user friendly package. Any diagnostic decisions based on data collected by Vital Signs are made by a healthcare professional. EUDAMED
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

Clinical & Handling

Sterile

No

EUDAMED

Category: Electrical-only medical device connection cable, reusable

Vs-7 by Byteflies NV — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Electrical-only medical device connection cable, reusable.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Byteflies NV
EUDAMED SRN
BE-PR-000033031

Sources (2)

  • EUDAMED 55566973-39b2-45d5-bc55-9c6228c420aa 61 fields · synced Jun 19, 2026
  • EUDAMED cd4d5182-e5f3-494b-a570-a90659f6f288 61 fields · synced Jun 19, 2026