Veye Lung Nodules

Organization name

Aidence B.V.

SRN

NL-MF-000000534

Manufacturer status

Active

B865VEYELUNGNOD0322X0

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

Primary placement in Netherlands; available across 11 countries total.

Trade name

Veye Lung Nodules

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.

B865VEYELUNGNOD0322X0

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.

++B865VeyeLungNodules4H

Reference / catalog number

3

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.

HIBCC

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Assist physicians in their review of CT scans in the detection, classification, quantification and growth assessment of solid and sub-solid pulmonary nodules using low-dose or standard-dose and non-contrast or post-contrast scans with a maximum axial slice thickness of ≤3mm. Veye lung Nodules is intended for use as a second or concurrent reader

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.

• Z11069092VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.