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EUDAMED last updated this device on May 4, 2026
B-08031527012735IT-MF-000029013No 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.
CW009CW001CW007Primary placement in Italy; available across 12 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Still on market | |
| Austria | Still on market | |
| Belgium | Still on market | |
| Czechia | Still on market | |
| Germany | Still on market | |
| EL | Still on market | |
| Spain | Still on market | |
| France | Still on market | |
| Netherlands | Still on market | |
| Norway | Still on market | |
| Portugal | Still on market | |
| Slovakia | Still on market |
(01)08031527012735
European Medical Device Nomenclature — the EU product classification assigned to this device.
J01010102IMPLANTABLE SINGLE CHAMBER PACEMAKERS WITH SENSOR (SR)