1.0

Organization name

Sleepiz AG

SRN

CH-MF-000011783

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW276

  Sleepiz One+ is not intended to be used by people with implanted electronic devices (active implants), such as pacemakers.
• CW023

  The minimum operating distance between Sleepiz One+ and the human body while it is operating is 6.5 cm. Violation of this safety distance for a prolonged time can lead to overexposure to electromagnetic waves.

Primary placement in Germany; available across 4 countries total.

Trade name

not provided

UDI-DI code

07649996477019

Basic UDI-DI

764999647701SY

Reference / catalog number

1.0

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

"Sleepiz One+ hardware unit uses radar technology to allow contactless monitoring of breathing patterns, respiration rate and heart rate during sleep or at rest. The hardware unit is intended to be used in combination with a web-based application displaying and analyzing signals analysis data sent by the hardware unit, and thus assists the software in achieving its medical purpose. The hardware unit can be used by a healthcare professional, when the recordings are performed in a clinical setting, or by a patient or his/her carer when the recordings are performed in home environment."

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12030280VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES

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

Certificate health across this manufacturer's portfolio.