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EUDAMED last updated this device on May 26, 2026
B-08033860017804IT-MF-000011601Certificate health across this manufacturer's portfolio.
IT349638Issued6 warnings recorded — scroll inside the panel to see all entries.
CW011CW010CW001CW009CW007CW032Primary placement in Italy; available across 14 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 | |
| Germany | Still on market | |
| EL | Still on market | |
| Spain | Still on market | |
| France | Still on market | |
| Netherlands | Still on market | |
| Poland | Still on market | |
| Portugal | Still on market | |
| Romania | Still on market | |
| Slovenia | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
K010301SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON