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EUDAMED last updated this device on Apr 28, 2026
42556501001-02GKDE-MF-000010098No 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.7 warnings recorded — scroll inside the panel to see all entries.
CW032CW029CW011CW001CW010CW009CW007Primary placement in Germany; available across 17 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Aug 12, 2025 | Jul 12, 2027 |
| Czechia | Aug 12, 2025 | Jul 12, 2027 |
| Denmark | Aug 12, 2025 | Jul 12, 2027 |
| EL | Aug 12, 2025 | Jul 12, 2027 |
| Spain | Aug 12, 2025 | Jul 12, 2027 |
| Finland | Aug 12, 2025 | Jul 12, 2027 |
| France | Aug 12, 2025 | Jul 12, 2027 |
| Hungary | Aug 12, 2025 | Jul 12, 2027 |
| Italy | Aug 12, 2025 | Jul 12, 2027 |
| Netherlands | Aug 12, 2025 | Jul 12, 2027 |
| Norway | Aug 12, 2025 | Jul 12, 2027 |
| Poland | Aug 12, 2025 | Jul 12, 2027 |
| Portugal | Aug 12, 2025 | Jul 12, 2027 |
| Romania | Aug 12, 2025 | Jul 12, 2027 |
| Sweden | Aug 12, 2025 | Jul 12, 2027 |
| Slovakia | Aug 12, 2025 | Jul 12, 2027 |
| Türkiye | Aug 12, 2025 | Jul 12, 2027 |
(01)04255650100440
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.
C0280ARRYTHMOLOGY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES