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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

TUBE 11x55 PP B/400 — IVDR Class A IVDR by Deltalab, S.L.

MD Atlas
Deltalab, S.L.

EUDAMED last updated this device on May 17, 2026

TUBE 11x55 PP B/400

84356058UDI-DI-156B

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: 08435263846522
Reference / catalog number: 400500.B

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Manufacturer information

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

Critical warnings

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

CW011
Healthcare professionals must validate the use of the container for their specific assay-instrument/reagent system combinations and specimen storage conditions.
CW010
• Not suitable for any application other than its intended use. • Do not squeeze or press the container. • Do not use if the product or any of its components is damaged. • Do not re-use. The re-use of this product may affect the subsequent analysis of the sample taken.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: TUBE 11x55 PP B/400
UDI-DI code: 08435263846522
Basic UDI-DI: 84356058UDI-DI-156B
Reference / catalog number: 400500.B
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: 10
Additional product description: —
Additional information URL: https://www.deltalabgroup.com/eifus
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05019099SAMPLES COLLECTION DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

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.

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

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