Sleepiz One+

Primary DI

07649996477309

Basic UDI-DI Code

7649996477WAXG

Reference

30

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Sleepiz AG

"The intended purpose of the Sleepiz One+ web application is to display and analyze data sent to it by the Sleepiz One+ hardware unit and/or other interoperable medical devices integrated with the web application. The web application allows the analysis and annotation of the data, compilation of results into reports and the management of the Sleepiz One+ hardware units. The outputs and functionality of the web application are intended to support decisions on diagnosis and management of patients with sleep apnea or other conditions, where variations in heart rate and respiration rate can indicate changes to the patient’s health status."

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