Bora Band

Primary DI

03770024064001

Basic UDI-DI Code

3770024064boraC8

Reference

BB-100_A00

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

BiOSENCY

Bora band ® is a wearable device used for measuring (intermittent data collection), recording, processing and storing physiological parameters that will later be transmitted to a web platform for remote monitoring to support the follow-up of patient’s care. There is no display on Bora band. Bora band measures, records and processes: - the functional oxygen saturation of arterial hemoglobin (%SpO2), - heart rate (HR), - respiratory rate (RR), - skin temperature (T°C). Bora band ® is suitable for use with adults with chronic respiratory diseases and satisfactory perfusion. It is intended for use at home, outdoors, and within medical settings. Bora band is intended to be used in combination with following software: Bora connect, EPOCA (EIIS), Dom’air santé.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).