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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

279062 — Class I MDR by Mobilex A/S

MD Atlas
Mobilex A/S

EUDAMED last updated this device on May 8, 2026

279062

57400014SOFTSLEEPH3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Mobilex A/S
UDI-DI code: 05740001403817
Reference / catalog number: 279062

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Manufacturer information

Organization name: Mobilex A/S
SRN: DK-MF-000021885
Manufacturer status: Active

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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.

Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05740001403817
Basic UDI-DI: 57400014SOFTSLEEPH3
Reference / catalog number: 279062
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The SoftSleep pillow is made of high-density, open-cell PU foam also called "Slow Foam" or "Memory Foam". This material has unique properties: it reacts to body weight and temperature fluctuations. Warmed by the user's body heat, it adapts its shape to the profile of the neck and head. Thanks to the shaping, the forces acting on the neck and head during sleep are alleviated and it helps eliminate headaches, neck and back pain. It can also help prevent or combat insomnia. The SoftSleep pillow thus increases the quality of sleep exceptionally.
Additional information URL: https://mobilex.dk/en/aids/various-aids/thermal-blanket-and-sleeping-bags/soft-sleep-contour-orthopedic-pillow-with-memory-foam-50-x-30-x-9-11-5-cm-w-x-d-x-h/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y99DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - OTHER

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

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