- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Aug 8, 2023
8406821BUG00274HKKE100005 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by GE Vingmed Ultrasound AS. Placed on the EU market in Norway. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
008406821157668406821BUG00274HKKE100005(01)00840682115766
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.
Z11040299ULTRASOUND PROBES – OTHER1 warning recorded — scroll inside the panel to see all entries.
CW010No certificate specifically references this device's Basic UDI-DI.
Primary placement in Norway; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| NorwayPrimary placement | Aug 7, 2023 | Jan 30, 2040 |
| Austria | Aug 7, 2023 | Jan 30, 2040 |
| Belgium | Aug 7, 2023 | Jan 30, 2040 |
| Bulgaria | Aug 7, 2023 | Jan 30, 2040 |
| Cyprus | Aug 7, 2023 | Jan 30, 2040 |
| Czechia | Aug 7, 2023 | Jan 30, 2040 |
| Germany | Aug 7, 2023 | Jan 30, 2040 |
| Denmark | Aug 7, 2023 | Jan 30, 2040 |
| Estonia | Aug 7, 2023 | Jan 30, 2040 |
| EL | Aug 7, 2023 | Jan 30, 2040 |
| Spain | Aug 7, 2023 | Jan 30, 2040 |
| Finland | Aug 7, 2023 | Jan 30, 2040 |
| France | Aug 7, 2023 | Jan 30, 2040 |
| Croatia | Aug 7, 2023 | Jan 30, 2040 |
| Hungary | Aug 7, 2023 | Jan 30, 2040 |
| Ireland | Aug 7, 2023 | Jan 30, 2040 |
| Iceland | Aug 7, 2023 | Jan 30, 2040 |
| Italy | Aug 7, 2023 | Jan 30, 2040 |
| Liechtenstein | Aug 7, 2023 | Jan 30, 2040 |
| Lithuania | Aug 7, 2023 | Jan 30, 2040 |
| Luxembourg | Aug 7, 2023 | Jan 30, 2040 |
| Latvia | Aug 7, 2023 | Jan 30, 2040 |
| Malta | Aug 7, 2023 | Jan 30, 2040 |
| Netherlands | Aug 7, 2023 | Jan 30, 2040 |
| Poland | Aug 7, 2023 | Jan 30, 2040 |
| Portugal | Aug 7, 2023 | Jan 30, 2040 |
| Romania | Aug 7, 2023 | Jan 30, 2040 |
| Sweden | Aug 7, 2023 | Jan 30, 2040 |
| Slovenia | Aug 7, 2023 | Jan 30, 2040 |
| Slovakia | Aug 7, 2023 | Jan 30, 2040 |
| Türkiye | Aug 7, 2023 | Jan 30, 2040 |
| XI | Aug 7, 2023 | Jan 30, 2040 |
NO-MF-000000553No 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.