- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Mar 24, 2022
B-7022750045035SSNO-MF-000013438Primary placement in Norway; available across 16 countries total.
| Country | On market since | Until |
|---|---|---|
| NorwayPrimary placement | Nov 1, 2021 | Dec 31, 2027 |
| Belgium | Nov 1, 2025 | Dec 31, 2027 |
| Cyprus | Jan 1, 2022 | Dec 31, 2027 |
| Germany | Nov 1, 2021 | Dec 31, 2027 |
| Denmark | Nov 1, 2021 | Dec 31, 2027 |
| Estonia | Jun 1, 2023 | Dec 31, 2027 |
| EL | Jan 1, 2022 | Dec 31, 2027 |
| Spain | Nov 1, 2021 | Dec 31, 2027 |
| France | Jun 1, 2023 | Dec 31, 2027 |
| Hungary | Jun 1, 2023 | Dec 31, 2027 |
| Italy | Nov 1, 2021 | Dec 31, 2027 |
| Luxembourg | Jun 1, 2023 | Dec 31, 2027 |
| Netherlands | Nov 1, 2025 | Dec 31, 2027 |
| Poland | Jun 1, 2023 | Dec 31, 2027 |
| Sweden | Nov 1, 2021 | Dec 31, 2027 |
| Türkiye | Jun 1, 2023 | Dec 31, 2027 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12050403ECG HOLTER RECORDERSNo 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.