Organization name

Deltalab, S.L.

SRN

ES-MF-000000153

Manufacturer status

Active

No certificate specifically references this device's Basic UDI-DI.

1 warning 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. Healthcare professionals must validate the use of the container for their specific assay-instrument/reagent system combinations and specimen storage conditions.

Primary placement in Spain; available across 20 countries total.

Trade name

60ML CONTAINER W/SPOON

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08435263816464

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

84356058UDI-DI-156B

Reference / catalog number

409552

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

600

Additional product description

—

Additional information URL

https://www.deltalabgroup.com/eifus

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• W05019099SAMPLES COLLECTION DEVICES - OTHER

• IVDR Class A medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.