Organization name

contextflow GmbH

SRN

AT-MF-000001773

Manufacturer status

Active

Primary placement in Austria; available across 14 countries total.

Trade name

contextflow ADVANCE Chest CT

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.

09120107330143

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.

912010733CFACHESTCT6J

Reference / catalog number

3.3.

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.

GS1

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

contextflow ADVANCE Chest CT is an AI-based, Computer Aided Detection (CADe) medical device software for 3D medical imaging data. It provides qualitative and quantitative analysis results and corresponding reference information relevant for the identification and interpretation of lung-specific image patterns in CT (Computed Tomograph) scans.

Additional information URL

https://contextflow.com/downloads

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.

• Z11030582RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.