Organization name

Fujirebio Europe N.V.

SRN

BE-MF-000001792

Manufacturer status

Active

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

• Consult instructions for use

Primary placement in Belgium; available across 30 countries total.

Trade name

Lumipulse pTau 217 Plasma Controls <2x2C, CE>

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.

05414470815463

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.

54144700375H

Reference / catalog number

81546

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 B

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

For in vitro diagnostic use as quality controls, to monitor the precision and accuracy of the Lumipulse G pTau 217 Plasma assay on the automated LUMIPULSE G System. This product is for professional use only.

Additional information URL

No additional information URL provided by the manufacturer.

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.

• W0102152003SPECIFIC PROTEIN CONTROLS

• IVDR Class B medical devices in EUDAMED

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