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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 HAEMOLYSIS PS 12X75 — IVDR Class A IVDR by Deltalab, S.L.

MD Atlas
Deltalab, S.L.

EUDAMED last updated this device on May 15, 2026

TUBE HAEMOLYSIS PS 12X75

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: 08435605815667
Reference / catalog number: TH5-12PS

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View device family (Basic UDI)

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
• 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.
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
France		Still on market

Device identification

Trade name: TUBE HAEMOLYSIS PS 12X75
UDI-DI code: 08435605815667
Basic UDI-DI: 84356058UDI-DI-156B
Reference / catalog number: TH5-12PS
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: 2
Additional product description: —
Additional information URL: https://www.deltalabgroup.com/eifus
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08435605815667

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

W05019099SAMPLES COLLECTION DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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