30

Organization name

Sleepiz AG

SRN

CH-MF-000011783

Manufacturer status

Active

Primary placement in Germany; available across 4 countries total.

Trade name

not provided

UDI-DI code

07649996477309

Basic UDI-DI

7649996477WAXG

Reference / catalog number

30

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

"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."

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12030282VITAL SIGNS MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

Certificate health across this manufacturer's portfolio.