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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

24 HOUR URINE SPECIMEN CONTAINER… — IVDR Class A IVDR

MD Atlas
Deltalab, S.L.

EUDAMED last updated this device on May 11, 2026

24 HOUR URINE SPECIMEN CONTAINER 3L W/LONG CANNULA

84356058UDI-DI-2166

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Deltalab, S.L.
UDI-DI code: 08435605801479
Reference / catalog number: 364984

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Manufacturer information

Organization name: Deltalab, S.L.
SRN: ES-MF-000000153
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

2024 PR 0038Issued
Quality assuranceNotified body: 0318Expiry: Oct 21, 2029

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
Be careful when handling the lid of the container which is containing a needle under the label. Take care also with the transfer cannula containing the needle. Not suitable for any application other than its intended use. Do not squeeze or press the container. Do not use if there are signs of breakage or damage to the container. Do not use if there is dirt in the container. Do not use if the needle forming the transfer system for sample collection is broken or bent when the label is removed from the cap. For single use only, for 24-hour urine collection. Do not reuse the product. Reuse of this product may affect subsequent analysis of the sample taken. o not use the product if the printed information is not displayed correctly. Do not use the product if the expiration date has been exceeded. Do not use if the printed information is not displayed correctly. Do not use if the expiry date has been exceeded.
CW011
Healthcare professionals must validate the use of the container for their specific assay instrument/reagent system combinations and specimen storage conditions.

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Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement		Still on market
Romania		Still on market

Device identification

Trade name: 24 HOUR URINE SPECIMEN CONTAINER 3L W/LONG CANNULA
UDI-DI code: 08435605801479
Basic UDI-DI: 84356058UDI-DI-2166
Reference / catalog number: 364984
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 30
Additional product description: —
Additional information URL: https://www.deltalabgroup.com/bd-eifus
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W05010203URINE COLLECTION, CONTAINERS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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