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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

P10021 — Class I MDR by Improving Mobility…

MD Atlas
Improving Mobility Development SL

EUDAMED last updated this device on Apr 4, 2025

P10021

436584K10000EDM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Improving Mobility Development SL
UDI-DI code: 08436584362746
Reference / catalog number: P10021

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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: 08436584362746
Basic UDI-DI: 436584K10000EDM
Reference / catalog number: P10021
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 PEPE silla de ruedas de autopropulsión tiene un diseño adaptado al autotransporte: las ruedas delanteras son pequeñas (Ø 19 cm) mientras que las ruedas traseras son más grandes (Ø 62 cm), y están acompañadas de aros de empuje que permiten la autopropulsión: al empujar los aros, las ruedas giran impulsando la silla hacia adelante o hacia atrás. No obstante, la silla está dotada de empuñaduras por si el usuario prefiere ser transportado. Cuenta también con reposabrazos, respaldo con bolsillo y asiento (46 x 40 cm) con cinturón con cierre para asegurar al paciente, reposapiés montables y desmontables y un sistema de frenos manual, que permite bloquearlas cuando la marcha está parada y asegurar la posición de la silla. Soporta un peso máximo de usuario de 113 kg.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y122106REAR SELF-PROPELLED WHEELCHAIRS

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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