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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

somnio — Class IIa MDR by mementor DE GmbH

MD Atlas
mementor DE GmbH

EUDAMED last updated this device on Jan 13, 2025

somnio

PP12257SOMNIO57

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: mementor DE GmbH
UDI-DI code: 1312257SOMNIO-V1067
Reference / catalog number: somnio

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Manufacturer information

Organization name: mementor DE GmbH
SRN: DE-MF-000007354
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Jan 7, 2025	Dec 31, 2039
France		Still on market

Device identification

Trade name: not provided
UDI-DI code: 1312257SOMNIO-V1067
Basic UDI-DI: PP12257SOMNIO57
Reference / catalog number: somnio
Issuing entity: IFA

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: somnio is a digital insomnia therapy for people that have difficulty initiating or maintaining sleep.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

This device is not currently linked to any other device.

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.