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EUDAMED last updated this device on Mar 13, 2026
B-08053847360297SMART FLOW Kit NIV Medium "WHITE" is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by GINEVRI srl. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08053847360297B-0805384736029712898C08(01)08053847360297
European Medical Device Nomenclature — the EU product classification assigned to this device.
R02010102BREATHING CIRCUITS, WITH WATER TRAP3 warnings recorded — scroll inside the panel to see all entries.
CW009CW020CW010No certificate specifically references this device's Basic UDI-DI.
Primary placement in Italy; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Still on market | |
| Austria | Still on market | |
| Belgium | Still on market | |
| Bulgaria | Still on market | |
| Cyprus | Still on market | |
| Czechia | Still on market | |
| Germany | Still on market | |
| Denmark | Still on market | |
| Estonia | Still on market | |
| EL | Still on market | |
| Spain | Still on market | |
| Finland | Still on market | |
| France | Still on market | |
| Croatia | Still on market | |
| Hungary | Still on market | |
| Ireland | Still on market | |
| Iceland | Still on market | |
| Liechtenstein | Still on market | |
| Lithuania | Still on market | |
| Luxembourg | Still on market | |
| Latvia | Still on market | |
| Malta | Still on market | |
| Netherlands | Still on market | |
| Norway | Still on market | |
| Poland | Still on market | |
| Portugal | Still on market | |
| Romania | Still on market | |
| Sweden | Still on market | |
| Slovenia | Still on market | |
| Slovakia | Still on market | |
| Türkiye | Still on market | |
| XI | Still on market |
IT-MF-000034527Certificate health across this manufacturer's portfolio.
IT350907AmendedIT256902