Organization name

Ortoiberica S.L.

SRN

ES-MF-000025780

Manufacturer status

Active

Primary placement in Spain; available across 32 countries total.

Trade name

FUNDA ESPUMA PREFORM C/CONO SUP DCH 44CM

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08431184007738

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

8431184P007VQ

Reference / catalog number

P-0077-003

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Cosmética para prótesis femoral fabricada en espuma poliéster en color carne y con una angulación de 30 grados. Especial para rodillas libres. Es fácil de rebajar y solo se suministra en color caucasiano. Para la elección del tallaje, hemos considerado como la "longitud", la distancia que hay del suelo al centro de la rodilla, y como perímetro el de la pantorrilla. Especial para rodillas P-1015 Comercializamos una espuma cosmética de las mismas características y tallas, pero con un vaciado en la parte superior para la colocación del encaje. El espacio interno es el mismo que la referencia P-0076 y por tanto es compatible para las mismas rodillas.

Additional information URL

https://www.ortoiberica.com/ortopedia-protesica-exogena-ortesica/cosmeticas/femoral-para-rodillas-libres_1022_988_9602_0_1_pro.html

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Y0699EXTERNAL PROSTHESES AND ORTHOSES - OTHER

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.