- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Feb 11, 2026
803365084AUS9AU F402 CH is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Chema Diagnostica Srl. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08033650840001803365084AUS9AU F402 CH(01)08033650840001
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01010232URIC ACID1 warning recorded — scroll inside the panel to see all entries.
CW084No certificate specifically references this device's Basic UDI-DI.
Primary placement in Italy; available across 8 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Jan 1, 2023 | Still on market |
| Belgium | Jan 1, 2023 | Still on market |
| Spain | Jan 1, 2023 | Still on market |
| Finland | Jan 1, 2023 | Still on market |
| France | Jan 1, 2023 | Still on market |
| Ireland | Jan 1, 2023 | Still on market |
| Luxembourg | Jan 1, 2023 | Still on market |
| Netherlands | Jan 1, 2023 | Still on market |
IT-MF-000009128No 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.