<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07340201503690</udiDi>
    <basicUdiDi>073402015BUDI000000019PS</basicUdiDi>
    <tradeName>Vantage Radiolucent Adapter for Doro</tradeName>
    <deviceName>Leksell Vantage Stereotactic System</deviceName>
    <manufacturerName>Elekta Solutions AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002125</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100601</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1136545</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:50:33.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340201504161</udiDi>
    <basicUdiDi>073402015BUDI000000003PB</basicUdiDi>
    <tradeName>Elekta Harmony</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elekta Solutions AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002125</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010102</emdnCode>
    <emdnDescription>MEDIUM AND MULTI ENERGY LINEAR ACCELERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1578932</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:01:48.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340201503898</udiDi>
    <basicUdiDi>073400483BUDI000000001ZQ</basicUdiDi>
    <tradeName>Leksell GammaPlan 11.5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elekta Solutions AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002125</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010782</emdnCode>
    <emdnDescription>RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1577756</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:01:47.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340201503676</udiDi>
    <basicUdiDi>073402015BUDI000000019PS</basicUdiDi>
    <tradeName>Leksell Vantage X-Ray Fiducial Box</tradeName>
    <deviceName>Leksell Vantage Stereotactic System</deviceName>
    <manufacturerName>Elekta Solutions AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002125</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100601</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1136431</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:01:46.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340201501269</udiDi>
    <basicUdiDi>073400483BUDI000000002ZS</basicUdiDi>
    <tradeName>FirmFix 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elekta Solutions AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002125</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100601</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1040031</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:01:45.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340201501023</udiDi>
    <basicUdiDi>073402015BUDI000000001P7</basicUdiDi>
    <tradeName>Kaiku Health</tradeName>
    <deviceName>Kaiku Health</deviceName>
    <manufacturerName>Elekta Solutions AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002125</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040192</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Kaiku Health major version 8</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:01:42.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340201500118</udiDi>
    <basicUdiDi>00858164002BUDI0000002H9</basicUdiDi>
    <tradeName>Monaco RTP System</tradeName>
    <deviceName>Monaco RTP System Software</deviceName>
    <manufacturerName>Elekta Solutions AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002125</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010492</emdnCode>
    <emdnDescription>RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Monaco 6.3</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:40:41.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340201503928</udiDi>
    <basicUdiDi>073402015BUDI000000019PS</basicUdiDi>
    <tradeName>Vantage Adapter for Mayfield</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elekta Solutions AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002125</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100601</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1578097</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T12:37:01.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340201503751</udiDi>
    <basicUdiDi>073402015BUDI000000019PS</basicUdiDi>
    <tradeName>Leksell Vantage X-Ray Table Fixation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elekta Solutions AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002125</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100601</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1136512</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:43:20.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340201503775</udiDi>
    <basicUdiDi>073402015BUDI000000019PS</basicUdiDi>
    <tradeName>Leksell Vantage X-Ray Universal Fixation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elekta Solutions AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002125</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100601</emdnCode>
    <emdnDescription>STEREOTACTIC NEUROSURGERY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1136528</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:43:20.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340201504178</udiDi>
    <basicUdiDi>073402015BUDI000000003PB</basicUdiDi>
    <tradeName>Elekta Harmony Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elekta Solutions AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002125</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010102</emdnCode>
    <emdnDescription>MEDIUM AND MULTI ENERGY LINEAR ACCELERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1578933</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:23:57.346Z</lastUpdated>
  </row>
</eudamedExport>