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Organization name
UDI-DI code
Reference / catalog number

COOPER — Class I MDR by Tecnoclínic SA

MD Atlas
Tecnoclínic SA

EUDAMED last updated this device on Dec 17, 2024

COOPER

843657368BCONSTNG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tecnoclínic SA
UDI-DI code: 08436573680684
Reference / catalog number: SALVA 2225507

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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
*Ce dispositif n'a pas de fonction de mesurage. Les indications de volume sont approximatives. *Risque de contamination et d'infection en cas de réutilisation du collecteur. *Le collecteur doit être vidé avant qu’il ne soit plein. *La poche de collecte doit être maintenue et placée sous le niveau de la vessie pour éviter tout reflux, *Bien fixer le connecteur à la sonde ou à l'étui pénien. *Contrôler que le robinet de vidange en croix est en position fermée. *Veiller à ne pas écraser, pincer ou plier la tubulure lors de l'utilisation pour éviter de restreindre l'écoulement de l'urine dans la poche.

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: COOPER
UDI-DI code: 08436573680684
Basic UDI-DI: 843657368BCONSTNG
Reference / catalog number: SALVA 2225507
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: 30
Additional product description: Poche à urine pour jambe 0.5L, avec valve anti-reflux, valve de vidange, tuyau 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

Related devices

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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.