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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

805008 — Class I MDR by Tecnoclínic SA

MD Atlas
Tecnoclínic SA

EUDAMED last updated this device on Apr 22, 2022

805008

843657368BCONSTNG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tecnoclínic SA
UDI-DI code: 08436572680067
Reference / catalog number: 805008

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Manufacturer information

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

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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 ser siempre colgada de un soporte, situándola por debajo del nivel de la vejiga urinaria para evitar reflujo. Fijar firmemente el conector a la sonda o adaptador penil. Asegurar que la válvula de salida esté cerrada. Evitar aplastar, pinzar o colapsar el tubo durante la utilización del producto para no interrumpir el flujo de la 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: 08436572680067
Basic UDI-DI: 843657368BCONSTNG
Reference / catalog number: 805008
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: 100
Additional product description: BOLSA COLECTORA ORINA 5L CIRCUITO CERRADO ESTÁNDAR CON VÁLVULA ANTIREFLUJO, VÁLVULA DE VACIADO, CONECTOR CON TOMA DE MUESTRAS Y CLAMP - TUBO 100 CM. - 100 UNIDADES
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