Organization name

Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH

SRN

AT-MF-000024115

Manufacturer status

Active

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

• GHS07 - Warning -Toxic cat. 4, Irritant cat. 2 or 3, Lower systemic health hazards
• H315 – Causes skin irritation.
• H317 – May cause an allergic skin reaction.
• H319 – Causes serious eye irritation.
• P264 – Wash thoroughly after handling.

Primary placement in Austria; available across 32 countries total.

Trade name

not provided

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.

09120036861046

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.

B-09120036861046

Reference / catalog number

5450311

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.

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The von Willebrand Factor (vWF) is a large, multifunctional glycoprotein, occupying a key position in primary haemostasis. It has a multiple structure with several functions: • It is the carrier protein for Factor VIII in plasma; it forms a complex and thus protects Factor VIII from early proteolytic decomposition. • It acts as a mediator for platelet aggregation by attaching itself to platelet membrane receptors (GP Ib and GP lIb/IIIa) following previous platelet activation. • It plays a part in primary haemostasis by acting as a mediator between adhesioned platelets and the subendothelium (lesioned vascular wall). In order to analyze the adhesive properties, as a rule the platelet aggregation is measured (measuring system = ristocetin-dependent platelet aggregation). However, this does not reflect the physiological setting nor the function of the vWF. For determining the adhesive properties of the vWF, its binding capacity to collagen serves as a parameter which corresponds to the physiological function of the vWF.

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.

• W0103020218COAGULATION FACTOR VON WILLEBRAND COLLAGEN BINDING ASSAY (CBA)

• IVDD — General medical devices in EUDAMED

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