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EUDAMED last updated this device on Mar 30, 2026
B-012138LESE-MF-000008549No 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.3 warnings recorded — scroll inside the panel to see all entries.
CW011CW009CW007Primary placement in Germany; available across 11 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market | |
| Austria | Still on market | |
| Belgium | Still on market | |
| Spain | Still on market | |
| France | Still on market | |
| Ireland | Still on market | |
| Luxembourg | Still on market | |
| Malta | Still on market | |
| Netherlands | Still on market | |
| Portugal | Still on market | |
| Slovenia | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
X0303SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE