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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

A0318 — Class I MDR by Tecnoclínic SA

MD Atlas
Tecnoclínic SA

EUDAMED last updated this device on Mar 31, 2025

A0318

8436573668BCOSTEX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tecnoclínic SA
UDI-DI code: 08436573680417
Reference / catalog number: A0318

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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

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

CW999
Non utilizare come strumento di misura. Il riutilizzo della sacca potrebbe comportare il rischio di infezioni. La sacca deve essere sostituta prima di raggiungere il livelo massimo. La sacca di raccolta deve essere sempre appesa a un sopporto. Fissare fermamente il connettore al catetere interno o al catetere esterno. Assicurarsi che la valvola di scarico sia chiusa. Fare attenzione a non schiacciare, bloccare o piegare il tubo per non limitare il flusso di urina in ingresso alla sacca.

Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08436573680417
Basic UDI-DI: 8436573668BCOSTEX
Reference / catalog number: A0318
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: Raccoglitore sterile per urina a circuito chiuso 2000 mL - tubo 120 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