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<eudamedExport entity="devices">
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    <udiDi>05056190500047</udiDi>
    <basicUdiDi>5056190501006UD</basicUdiDi>
    <tradeName>Head Adjuster</tradeName>
    <deviceName>Head Adjuster</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>MDR 2017/745</legislation>
    <emdnCode>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05056190500047</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:16.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056190500863</udiDi>
    <basicUdiDi>5056190501082UV</basicUdiDi>
    <tradeName>Calibration Cube and Levelling Plate</tradeName>
    <deviceName>Calibration Cube</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>MDR 2017/745</legislation>
    <emdnCode>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Calibration Cube Mk2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:15.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056190500894</udiDi>
    <basicUdiDi>5056190501075UY</basicUdiDi>
    <tradeName>DoseRT reference board</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>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DoseRT reference board</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:15.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056190501259</udiDi>
    <basicUdiDi>5056190501075UY</basicUdiDi>
    <tradeName>DoseRT camera-computer interface 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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DoseRT camera interface box</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:15.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056190501266</udiDi>
    <basicUdiDi>5056190501075UY</basicUdiDi>
    <tradeName>DoseRT camera isolation transformer</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>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DoseRT isolation transformer</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:15.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>05419980263100</udiDi>
    <basicUdiDi>54199802631OABCZU</basicUdiDi>
    <tradeName>OABC BC5</tradeName>
    <deviceName>Open Access Breast Couch BC5</deviceName>
    <manufacturerName>RADIation ONcology-Devices</manufacturerName>
    <manufacturerSrn>BE-MF-000003424</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OABC BC5</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:07:18.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946673</udiDi>
    <basicUdiDi>0850019946MRPHANTOMSA</basicUdiDi>
    <tradeName>MR Grid Phantom</tradeName>
    <deviceName>MR Grid Phantom</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>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91635</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:37.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946727</udiDi>
    <basicUdiDi>0850019946MACHINEQA95</basicUdiDi>
    <tradeName>TG-142 Phantom</tradeName>
    <deviceName>TG-142 Phantom</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>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91625</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:36.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946567</udiDi>
    <basicUdiDi>0850019946RECONJIGXH</basicUdiDi>
    <tradeName>Reconstruction Jig (Large)</tradeName>
    <deviceName>Reconstruction Jig</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>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91280</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:18.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946550</udiDi>
    <basicUdiDi>0850019946IMRTPHANTOMLR</basicUdiDi>
    <tradeName>IMRT Phantom</tradeName>
    <deviceName>IMRT Phantom</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>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91230</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:17.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946536</udiDi>
    <basicUdiDi>0850019946WLUTZPHANTOMMC</basicUdiDi>
    <tradeName>Winston Lutz Cube Phantom</tradeName>
    <deviceName>Winston Lutz Cube Phantom</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>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91345</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:16.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946529</udiDi>
    <basicUdiDi>0850019946SDVPHANTOMNS</basicUdiDi>
    <tradeName>Stereotactic Dose Verification Phantom</tradeName>
    <deviceName>SDVP Phantom</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>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91250</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:14.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946512</udiDi>
    <basicUdiDi>0850019946MIMIPHANTOMAV</basicUdiDi>
    <tradeName>MIMI Phantom</tradeName>
    <deviceName>MIMI Phantom</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>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91240</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:13.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946505</udiDi>
    <basicUdiDi>0850019946LUCYPHANTOMP4</basicUdiDi>
    <tradeName>LUCY 3D QA Phantom</tradeName>
    <deviceName>LUCY Phantom</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>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91210</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:10.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056719001001</udiDi>
    <basicUdiDi>04056719BUDI0000000003HY</basicUdiDi>
    <tradeName>iBEAM Indexing Bar (Set of 3)</tradeName>
    <deviceName>iBEAM evo Couchtop, iBEAM one Couchtop</deviceName>
    <manufacturerName>3C-Medical Intelligence GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023763</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P10105-110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:10:08.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481125967</udiDi>
    <basicUdiDi>4056481PatientMask38</basicUdiDi>
    <tradeName>Patient Mask Set</tradeName>
    <deviceName>Patient Mask Set</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>41130</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:33:23.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481002589</udiDi>
    <basicUdiDi>4056481FramelessCT</basicUdiDi>
    <tradeName>Frameless SRS CARBON BASE</tradeName>
    <deviceName>Frameless SRS</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>43405-01A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:32:50.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481145361</udiDi>
    <basicUdiDi>4056481Cranial4PiW&amp;SAV</basicUdiDi>
    <tradeName>Cranial 4PI Wedge 10 Deg.</tradeName>
    <deviceName>Cranial 4Pi Wedges and Spacers</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>43455</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:30:30.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481144234</udiDi>
    <basicUdiDi>4056481Cranial4PiOverlaXA</basicUdiDi>
    <tradeName>Cranial 4PI Treatment Overlay</tradeName>
    <deviceName>Cranial 4Pi Overlays</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>43421A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:30:19.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481144210</udiDi>
    <basicUdiDi>4056481Cranial4PiHeadReHT</basicUdiDi>
    <tradeName>Cranial 4PI Headrest Low-Neck</tradeName>
    <deviceName>Cranial 4Pi Headrests</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019080</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>43441A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:30:18.441Z</lastUpdated>
  </row>
</eudamedExport>