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EUDAMED last updated this device on May 6, 2026
073402015BUDI000000003PBElekta Harmony is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Elekta Solutions AB. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
07340201504161073402015BUDI000000003PB1578932(01)07340201504161
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.
Z11010102MEDIUM AND MULTI ENERGY LINEAR ACCELERATORS1 warning recorded — scroll inside the panel to see all entries.
CW010No certificate specifically references this device's Basic UDI-DI.
Primary placement in Sweden; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | Still on market | |
| Austria | Still on market | |
| Belgium | Still on market | |
| Bulgaria | Still on market | |
| Cyprus | Still on market | |
| Czechia | Still on market | |
| Germany | Still on market | |
| Denmark | Still on market | |
| Estonia | Still on market | |
| EL | Still on market | |
| Spain | Still on market | |
| Finland | Still on market | |
| France | Still on market | |
| Croatia | Still on market | |
| Hungary | Still on market | |
| Ireland | Still on market | |
| Iceland | Still on market | |
| Italy | Still on market | |
| Liechtenstein | Still on market | |
| Lithuania | Still on market | |
| Luxembourg | Still on market | |
| Latvia | Still on market | |
| Malta | Still on market | |
| Netherlands | Still on market | |
| Norway | Still on market | |
| Poland | Still on market | |
| Portugal | Still on market | |
| Romania | Still on market | |
| Slovenia | Still on market | |
| Slovakia | Still on market | |
| Türkiye | Still on market | |
| XI | Still on market |
SE-MF-000002125No 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.