Devices (same UDI-DI)
1
Certificates
0
Countries
4
Notified Bodies
0
Basic Information
- Primary DI
- 07649996477019
- Basic UDI-DI Code
- 764999647701SY
- Reference
- 1.0
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Sleepiz AG
Additional 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."
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12030280 | VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES |
Available In Countries
🇦🇹 Austria
🇩🇪 Germany
🇫🇷 France
🇮🇹 Italy
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