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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

Sleepiz One+ — Class IIa MDR by Sleepiz AG

MD Atlas
Sleepiz AG

EUDAMED last updated this device on Dec 24, 2025

Sleepiz One+

7649996477NGCS012U

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sleepiz AG
UDI-DI code: 07649996477095
Reference / catalog number: 09

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Manufacturer information

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

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Aug 8, 2025	Still on market

Device identification

Trade name: Sleepiz One+
UDI-DI code: 07649996477095
Basic UDI-DI: 7649996477NGCS012U
Reference / catalog number: 09
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: The Sleepiz One+ API enables secure access to physiological data collected by the Sleepiz One+ hardware unit. It allows health care professionals (HCPs), EHR systems, and third-party health analytics platforms to retrieve time-series health data to aid ongoing clinical care, long-term patient monitoring, and research purposes.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030282VITAL SIGNS MONITORING INSTRUMENTS - SOFTWARE 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

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Certificates

Certificate health across this manufacturer's portfolio.

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