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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

K40003 — Class I MDR by Improving Mobility…

MD Atlas
Improving Mobility Development SL

EUDAMED last updated this device on Apr 3, 2025

K40003

436584K40000AEL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Improving Mobility Development SL
UDI-DI code: 08436584360957
Reference / catalog number: K40003

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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: 08436584360957
Basic UDI-DI: 436584K40000AEL
Reference / catalog number: K40003
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 diseñado para colocar en el asiento o el respaldo de sillas de ruedas. Su interior está compuesto por una capa de 4 cm de espuma viscoelástica y una capa de 4 cm de espuma de poliuretano, con una densidad total de 23 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 y adaptabilidad medias y soporta un peso máximo de usuario de 100 kg. Sus dimensiones son 42 x 42 x 8 cm (largo x ancho x alto).
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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