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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

04 — Class IIa MDR by Sleepiz AG

MD Atlas
Sleepiz AG

EUDAMED last updated this device on Sep 3, 2025

04

7649996477025L4

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sleepiz AG
UDI-DI code: 07649996477040
Reference / catalog number: 04

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Manufacturer information

Organization name: Sleepiz AG
SRN: CH-MF-000011783
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW023
The minimum operating distance between Sleepiz One+ and the human body while it is operating is 20 cm. Violation of this safety distance for a prolonged time can lead to overexposure to electromagnetic waves.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Aug 4, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07649996477040
Basic UDI-DI: 7649996477025L4
Reference / catalog number: 04
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Sleepiz One+ is a contactless medical device that uses radar technology to measure respiration rate and heart rate from a resting or sleeping patient. The Sleepiz One+ consists of a hardware unit and cloud-based software The hardware unit can be positioned on a bedside table, mounted on a stand, or attached to the wall behind the patient’s bed. It is designed to monitor physiological signals by detecting small body movements, such as those caused by breathing and heartbeat, using Doppler radar. The recorded signals are then transmitted via Wi-Fi to cloud-based software, where they are analyzed to obtain respiration rate, heart rate, and body movement. These outputs can be exposed via the Application Programming Interfaces (APIs) to allow healthcare professionals the review and annotation of the data and compilation of results into reports.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030280VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Sleepiz One+7649996477NGCS012UOn the market 05764999647703T4On the market 1.0764999647701SYOn the market 307649996477WAXGOn the market 407649996477PP02QEOn the market

Certificates

Certificate health across this manufacturer's portfolio.

G10 104055 0002Issued
Quality management systemNotified body: 0123Expiry: Nov 15, 2026