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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

K40053 — Class I MDR by Improving Mobility…

MD Atlas
Improving Mobility Development SL

EUDAMED last updated this device on Apr 3, 2025

K40053

436584K40000AEL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Improving Mobility Development SL
UDI-DI code: 08436584362968
Reference / catalog number: K40053

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Manufacturer information

Organization name: Improving Mobility Development SL
SRN: ES-MF-000010985
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 Spain; available across 1 country total.

Placed on the market in Spain; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08436584362968
Basic UDI-DI: 436584K40000AEL
Reference / catalog number: K40053
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: La almohada para oreja azul está recomendada para reducir molestias en el pabellón auricular, ya sea para usuarios que deben liberar la presión de la oreja o para pacientes que padecen condrodermatitis. Cuenta con un orificio central de 10 cm de diámetro que reduce la presión en la zona de la oreja y sus dimensiones son 45 x 35 x 12 cm (largo x ancho x alto). Es un cojín bilateral fabricado con relleno de fibra de poliéster y recubierto de tela de bambú, un tejido muy absorbente y con micro agujeros que favorecen la transpiración evitando los malos olores.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V080399MEDICAL CUSHIONS - 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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