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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

X-5021-004 — Class I MDR by Ortoiberica S.L.

MD Atlas
Ortoiberica S.L.

EUDAMED last updated this device on Feb 28, 2024

X-5021-004

8431184X5021Q5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ortoiberica S.L.
UDI-DI code: 08431184502141
Reference / catalog number: X-5021-004

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Manufacturer information

Organization name: Ortoiberica S.L.
SRN: ES-MF-000025780
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: 08431184502141
Basic UDI-DI: 8431184X5021Q5
Reference / catalog number: X-5021-004
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: Férula de Bunnell extensora activa indicada para las secciones del extensor del dedo, capsulitis retráctiles, rigideces y como férula nocturna en deformidad ojal o boutonniére contractura en flex de la IFP. Lesiones postraumáticas o postquirúrgicas, esguinces colaterales. Férula simétrica, vale tanto para el lado derecho como para el izquierdo. Para escoger correctamente la talla descargue el archivo PDF que aparece en documentos relacionados.
Additional information URL: https://www.ortoiberica.com/ortopedia-protesica-exogena-ortesica/ortesis-de-dedo-dinamicas/ferula-activa-extensora-de-dedos_788_956_9646_0_1_pro.html
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y061803PARTIAL HAND PROSTHESES (INCLUDING FINGERS PROSTHESES)

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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Expiration date
Manufacturing date
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Software identification