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FR-MF-000042615IMMUNO-TROL i-Tracker Risankizumab is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by BIOSYNEX. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Sep 9, 2025
353267CTRZ002PCAQZPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)03532672000424
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
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.
Primary placement in France; available across 14 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Sep 8, 2025 | Still on market |
| Austria | Sep 8, 2025 | Still on market |
| Belgium | Sep 8, 2025 | Still on market |
| Czechia | Sep 8, 2025 | Still on market |
| Germany | Sep 8, 2025 | Still on market |
| Spain | Sep 8, 2025 | Still on market |
| Ireland | Sep 8, 2025 | Still on market |
| Italy | Sep 8, 2025 | Still on market |
| Liechtenstein | Sep 8, 2025 | Still on market |
| Luxembourg | Sep 8, 2025 | Still on market |
| Malta | Sep 8, 2025 | Still on market |
| Netherlands | Sep 8, 2025 | Still on market |
| Portugal | Sep 8, 2025 | Still on market |
| Sweden | Sep 8, 2025 | 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.
03532672000424Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
353267CTRZ002PCAQZCTRZ 002-PCUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102152001TDM/DRUG CONTROLSNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.B-03532672000387On the marketIMMUNO-TROL i-Tracker InfliximabB-03532672000288On the marketIMMUNO-TROL i-Tracker Ocrelizumab353267CTO002PCAWWOn the marketIMMUNO-TROL i-Tracker RituximabB-03532672000400On the marketIMMUNO-TROL i-Tracker UstekinumabB-03532672000301On the marketIMMUNO-TROL i-Tracker VedolizumabB-03532672000325On the marketNo certificate specifically references this device's Basic UDI-DI.