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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

K40017 — Class I MDR by Improving Mobility…

MD Atlas
Improving Mobility Development SL

EUDAMED last updated this device on Apr 3, 2025

K40017

436584K40000AEL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Improving Mobility Development SL
UDI-DI code: 08436584361954
Reference / catalog number: K40017

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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: 08436584361954
Basic UDI-DI: 436584K40000AEL
Reference / catalog number: K40017
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: Se trata de un cojín redondo con forma de donut diseñado para colocar en sillas de ruedas, de tal manera que el usuario se siente sobre él. Está especialmente recomendado para usuarios que sufren de hemorroides o para pacientes que han sido intervenidos de fístulas o de lesiones en el coxis. Su interior está compuesto por una lámina de 9 cm de espuma viscoelástica y tiene una densidad total de 65,3 kg/m3. La parte exterior es una funda antibacterias, antihongos y antiácaros fabricada en tejido 3D que es lavable, transpirable, impermeable y antideslizante. Este cojín previene la aparición de escaras o úlceras de decúbito propias de los cuerpos que permanecen inmóviles durante un largo periodo de tiempo. Ofrece una dureza alta y una adaptabilidad muy alta y soporta un peso máximo de usuario de 100 kg. Sus dimensiones son 42,5 x 42,5 x 9 cm (largo x ancho x alto). El agujero del centro tiene una anchura de 13 cm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V08030102NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS

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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