- Role
- Country
- Date of registration
- Address
AT-MF-000001773(01)09120107330044
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Austria; available across 12 countries total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | — | Still on market |
| Belgium | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Sweden | — | Still on market |
| XI | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
09120107330044Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
912010733CFSLUNGCT4Csoftware version 1.3UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z11030582RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIEScontextflow SEARCH Lung CT is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by contextflow GmbH. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Mar 29, 2022
912010733CFSLUNGCT4CPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
No certificate specifically references this device's Basic UDI-DI.
912010733CFACHESTCT6JOn the marketcontextflow ADVANCE Chest CT912010733CFACHESTCT6JOn the marketcontextflow ADVANCE Chest CT912010733CFACHESTCT6JOn the marketcontextflow SEARCH Lung CT912010733CFSLUNGCT4COn the marketcontextflow SEARCH Lung CT912010733CFSLUNGCT4COn the marketcontextflow SEARCH Lung CT912010733CFSLUNGCT4COn the marketCertificate health across this manufacturer's portfolio.
G10 103663 0002IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
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