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<eudamedExport entity="devices">
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    <udiDi>05056190501211</udiDi>
    <basicUdiDi>5056190500573VE</basicUdiDi>
    <tradeName>AlignRT 8.1.x</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vision RT Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000010499</manufacturerSrn>
    <authorisedRepresentativeName>Oticon A/S</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000006135</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AlignRT 8.1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:15.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056190501228</udiDi>
    <basicUdiDi>5056190500573VE</basicUdiDi>
    <tradeName>AlignRT InBore Radixact PIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vision RT Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000010499</manufacturerSrn>
    <authorisedRepresentativeName>Oticon A/S</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000006135</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V001094</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:15.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056190501235</udiDi>
    <basicUdiDi>5056190500573VE</basicUdiDi>
    <tradeName>AlignRT InBore Accuray Fibre Hub</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vision RT Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000010499</manufacturerSrn>
    <authorisedRepresentativeName>Oticon A/S</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000006135</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AlignRT InBore Accuray Fibre Hub</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:15.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056190501242</udiDi>
    <basicUdiDi>5056190500573VE</basicUdiDi>
    <tradeName>DoseRT Phase 1b workstation</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vision RT Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000010499</manufacturerSrn>
    <authorisedRepresentativeName>Oticon A/S</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000006135</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DoseRT workstation</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:15.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056190501280</udiDi>
    <basicUdiDi>5056190500573VE</basicUdiDi>
    <tradeName>Mevion Interface Unit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vision RT Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000010499</manufacturerSrn>
    <authorisedRepresentativeName>Oticon A/S</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000006135</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V000994</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:15.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056190501297</udiDi>
    <basicUdiDi>5056190501013UA</basicUdiDi>
    <tradeName>Real Time Coach Mk3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vision RT Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000010499</manufacturerSrn>
    <authorisedRepresentativeName>Oticon A/S</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000006135</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5056190501297</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:15.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056190501303</udiDi>
    <basicUdiDi>5056190500573VE</basicUdiDi>
    <tradeName>AlignRT 8.2.x</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vision RT Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000010499</manufacturerSrn>
    <authorisedRepresentativeName>Oticon A/S</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000006135</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AlignRT InBore 8.2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:15.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056190501334</udiDi>
    <basicUdiDi>5056190500573VE</basicUdiDi>
    <tradeName>AlignRT InBore Accuray Control Box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vision RT Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000010499</manufacturerSrn>
    <authorisedRepresentativeName>Oticon A/S</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000006135</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V001127</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:15.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056190501372</udiDi>
    <basicUdiDi>5056190500573VE</basicUdiDi>
    <tradeName>AlignRT InBore Accuray</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vision RT Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000010499</manufacturerSrn>
    <authorisedRepresentativeName>Oticon A/S</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000006135</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05056190501372</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:14.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060494200046</udiDi>
    <basicUdiDi>B-05060494200046</basicUdiDi>
    <tradeName>Xstrahl 200 Therapeutic X-Ray System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xstrahl Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000031943</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X200F</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-19T15:27:36.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060494200039</udiDi>
    <basicUdiDi>B-05060494200039</basicUdiDi>
    <tradeName>Xstrahl 150 Therapeutic X-Ray System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xstrahl Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000031943</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X150C</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-19T15:27:32.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060494200022</udiDi>
    <basicUdiDi>B-05060494200022</basicUdiDi>
    <tradeName>Xstrahl 150 Therapeutic X-Ray System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xstrahl Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000031943</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X150F</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-19T15:27:31.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060494200015</udiDi>
    <basicUdiDi>B-05060494200015</basicUdiDi>
    <tradeName>Xstrahl 100 Therapeutic X-Ray System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xstrahl Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000031943</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X100</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-19T15:27:29.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060494200008</udiDi>
    <basicUdiDi>B-05060494200008</basicUdiDi>
    <tradeName>Xstrahl 80 Therapeutic X-Ray System (RADiant)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xstrahl Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000031943</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X80</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-19T15:27:29.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946680</udiDi>
    <basicUdiDi>0850019946HEADHOLDERTU</basicUdiDi>
    <tradeName>TruPose Head Adjuster</tradeName>
    <deviceName>TruPose Head Adjuster</deviceName>
    <manufacturerName>Standard Imaging, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009855</manufacturerSrn>
    <authorisedRepresentativeName>Hoff &amp; Lowendahl AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001888</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91710</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:38.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946482</udiDi>
    <basicUdiDi>0850019946EXRADINSCINTIQF</basicUdiDi>
    <tradeName>Exradin W1 Scintillator</tradeName>
    <deviceName>Exradin Scintillator</deviceName>
    <manufacturerName>Standard Imaging, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009855</manufacturerSrn>
    <authorisedRepresentativeName>Hoff &amp; Lowendahl AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001888</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92739</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:10.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946468</udiDi>
    <basicUdiDi>0850019946EXRADINDIODEAY</basicUdiDi>
    <tradeName>Exradin D1V Diode</tradeName>
    <deviceName>Exradin Scanning Diode</deviceName>
    <manufacturerName>Standard Imaging, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009855</manufacturerSrn>
    <authorisedRepresentativeName>Hoff &amp; Lowendahl AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001888</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92740</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:08.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946116</udiDi>
    <basicUdiDi>0850019946QACHECKER94</basicUdiDi>
    <tradeName>QA BeamChecker Plus</tradeName>
    <deviceName>QA Beam Analyzer</deviceName>
    <manufacturerName>Standard Imaging, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009855</manufacturerSrn>
    <authorisedRepresentativeName>Hoff &amp; Lowendahl AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001888</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90501</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:03.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>B850033600050</udiDi>
    <basicUdiDi>++B85003360005CK</basicUdiDi>
    <tradeName>X-BEAM</tradeName>
    <deviceName>X-BEAM</deviceName>
    <manufacturerName>Gilardoni SPA</manufacturerName>
    <manufacturerSrn>IT-MF-000008874</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X-BEAM</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:02:24.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>B850033600030</udiDi>
    <basicUdiDi>++B85003360003CF</basicUdiDi>
    <tradeName>RADGIL2</tradeName>
    <deviceName>RADGIL2</deviceName>
    <manufacturerName>Gilardoni SPA</manufacturerName>
    <manufacturerSrn>IT-MF-000008874</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RADGIL2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:02:20.913Z</lastUpdated>
  </row>
</eudamedExport>