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Organization name
UDI-DI code
Reference / catalog number

29510-804226 — Class I MDR by Tecnoclínic SA

MD Atlas
Tecnoclínic SA

EUDAMED last updated this device on Apr 29, 2022

29510-804226

843657368BCONSTNG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tecnoclínic SA
UDI-DI code: 04046964504204
Reference / catalog number: 29510-804226

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Manufacturer information

Organization name: Tecnoclínic SA
SRN: ES-MF-000000632
Manufacturer status: Active

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Critical warnings

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

CW999
Do not use as measuring device. Product reuse could cause infection risk. The bag should be substituted before reaching the maximum level. The collection bag must be hold onto the leg through elastic straps placing it below the level of the urinary bladder to avoid reflux. Fix firmly the connector to the prove or penile adaptor. Make sure that the drain tap is closed. Be careful not to crush, clamp or collapse the tube while using the product to avoid restricting the flow of urine into the bag.

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: 04046964504204
Basic UDI-DI: 843657368BCONSTNG
Reference / catalog number: 29510-804226
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: 100
Additional product description: LEG URINE COLLECTION BAG
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

Certificates

Certificate health across this manufacturer's portfolio.

CGP000124Issued
Quality assuranceNotified body: 0373Expiry: Apr 15, 2029