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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

A0307 — Class I MDD by Tecnoclínic SA

MD Atlas
Tecnoclínic SA

EUDAMED last updated this device on Apr 22, 2022

A0307

B-08436573680158

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Tecnoclínic SA
UDI-DI code: 08436573680158
Reference / catalog number: A0307

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Manufacturer information

Organization name: Tecnoclínic SA
SRN: ES-MF-000000632
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.

Critical warnings

2 warnings 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 vaciado está cerrada. Evitar aplastar, pinzar o colapsar el tubo durante la utilización del producto para no interrumpir el flujo de orina hacia la bolsa.
CW007
EUDAMED did not publish a description for this code.

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: 08436573680158
Basic UDI-DI: B-08436573680158
Reference / catalog number: A0307
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: BOLSA COLECTORA ORINA 2L CON VÁLVULA ANTIREFLUJO Y VÁLVULA DE VACIADO - TUBO 90 CM. - 250 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