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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

CAREBAG, KIT DE RECUEIL DES… — Class I MDR by CLEANIS

MD Atlas
CLEANIS

EUDAMED last updated this device on Aug 27, 2025

CAREBAG, KIT DE RECUEIL DES URINES SUR 24 H

376005923RECUEILEXCDT05B8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CLEANIS
UDI-DI code: 03760059239833
Reference / catalog number: 9829559

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Manufacturer information

Organization name: CLEANIS
SRN: FR-MF-000004677
Manufacturer status: Active

Critical warnings

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

CW999
Vérifier la date de péremption avant utilisation. Ne pas utiliser en cas de défaillance du produit empêchant son utilisation. Ne pas uriner directement dans le bocal. Port de gants recommandé. Sachet de poudre avec film hydrosoluble: ne pas ouvrir et ne pas manipuler avec les mains humides. En cas de contact de la poudre des sachets avec l’œil ou les muqueuses, rincer abondamment à l’eau et contacter un médecin si nécessaire. En cas d'ingestion de la poudre des sachets consulter immédiatement un médecin et lui montrer l'emballage.

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: CAREBAG, KIT DE RECUEIL DES URINES SUR 24 H
UDI-DI code: 03760059239833
Basic UDI-DI: 376005923RECUEILEXCDT05B8
Reference / catalog number: 9829559
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: 200
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0880MEDICAL SUPPORT EQUIPMENT - ACCESSORIES

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

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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.