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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

5072FR-807095 — Class I MDR by Tecnoclínic SA

MD Atlas
Tecnoclínic SA

EUDAMED last updated this device on May 2, 2022

5072FR-807095

843657368BCOURTMACSRS2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tecnoclínic SA
UDI-DI code: 08436573680387
Reference / catalog number: 5072FR-807095

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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
Do not re-use. If you note any change on your stoma and/or peristomal skin, please contact your health care professional. Do not use as a measuring device. The bag should be substituted before reaching the maximum level. Be careful not to crush, clamp or collapse the tube while using the product to avoid restricting the flow of urine into the bag. Reuse of single-use devices creates a potential risk to the patient. It may lead to contamination and/or impairment of functional capability" One B. Braun Uribag is for single patient only and can be used for a duration of about 72 hours. The single use stoma care products cannot be reprocessed.

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: not provided
UDI-DI code: 08436573680387
Basic UDI-DI: 843657368BCOURTMACSRS2
Reference / catalog number: 5072FR-807095
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 DE RECUEIL, 2L CONNECTABLE AUX POCHES D'UROSTOMIE
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