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Organization name
UDI-DI code
Reference / catalog number

Biopierna N/W - 804215 — Class I MDR by Tecnoclínic SA

MD Atlas
Tecnoclínic SA

EUDAMED last updated this device on Dec 17, 2024

Biopierna N/W - 804215

843657368BCONSTNG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tecnoclínic SA
UDI-DI code: 04046964448362
Reference / catalog number: Biopierna N/W - 804215

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Manufacturer information

Organization name: Tecnoclínic SA
SRN: ES-MF-000000632
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
* No utilizar como instrumento de medición. * La reutilización de la bolsa podría comportar riesgo de infección. * Se debe sustituir la bolsa antes de alcanzar el nivel máximo. * La bolsa colectora debe sujetarse a la pierna a través de cintas elásticas , situándola por debajo del nivel de la vejiga urinaria para evitar reflujo. * Fijar firmemente el conector a la sonda o adaptador penil. * Evitar aplastar, pinzar o colapsar el tubo durante la utilización del producto para no interrumpir el flujo de orina hacia la bolsa.

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: 04046964448362
Basic UDI-DI: 843657368BCONSTNG
Reference / catalog number: Biopierna N/W - 804215
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: 300
Additional product description: Bolsa colectora de orina de pierna 0.75L, con válvula anti-retorno, válvula de vaciado, tubo 50 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)

A06030301URINE COLLECTION BAGS

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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

CGP000124Issued
Quality assuranceNotified body: 0373Expiry: Apr 15, 2029

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