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<eudamedExport entity="devices">
  <row>
    <udiDi>00866562000298</udiDi>
    <basicUdiDi>08665620002QAPILOTJF</basicUdiDi>
    <tradeName>QA Pilot</tradeName>
    <deviceName>QA Pilot</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>Z11010182</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91348</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:00:32.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>00866562000236</udiDi>
    <basicUdiDi>08665620002PIPSPROPX</basicUdiDi>
    <tradeName>PIPSpro</tradeName>
    <deviceName>PIPSpro</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>Z11010182</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91309</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:00:28.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>00866562000212</udiDi>
    <basicUdiDi>08665620002WELLCHAMBERAQ</basicUdiDi>
    <tradeName>HDR 1000 Plus</tradeName>
    <deviceName>Well Chamber</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>Z11010380</emdnCode>
    <emdnDescription>BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90008</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:00:28.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>00866562000267</udiDi>
    <basicUdiDi>08665620002LINACVIEWHF</basicUdiDi>
    <tradeName>LinacView</tradeName>
    <deviceName>LinacView</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>Z11010182</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91330</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:00:27.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>00866562000243</udiDi>
    <basicUdiDi>08665620002ADAPTIVONV</basicUdiDi>
    <tradeName>Adaptivo</tradeName>
    <deviceName>Adaptivo</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>Z11010182</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91350</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:00:26.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>00864366000117</udiDi>
    <basicUdiDi>08643660001S250L2</basicUdiDi>
    <tradeName>MEVION S250-FIT Proton Therapy System</tradeName>
    <deviceName>MEVION S250-FIT Proton Therapy System</deviceName>
    <manufacturerName>Mevion Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008692</manufacturerSrn>
    <authorisedRepresentativeName>Regulatory Quality Management Information Source AREU, S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000002139</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11011001</emdnCode>
    <emdnDescription>PROTON THERAPY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S250-FIT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:59:55.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946642</udiDi>
    <basicUdiDi>08665620002DOSEVIEWZD</basicUdiDi>
    <tradeName>DoseView 3D Helical</tradeName>
    <deviceName>QA Water 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>Z11010180</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92250</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:58:25.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946543</udiDi>
    <basicUdiDi>08665620002IMSURE8S</basicUdiDi>
    <tradeName>IMSure 3D</tradeName>
    <deviceName>IMSure</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>Z11010182</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91365</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:58:24.671Z</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>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>00850019946611</udiDi>
    <basicUdiDi>0850019946SEEDPOUCHKH</basicUdiDi>
    <tradeName>Protective Lead Seed Pouch</tradeName>
    <deviceName>Protective Lead Seed Pouch</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>Z11010380</emdnCode>
    <emdnDescription>BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90080</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:21.391Z</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>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>
</eudamedExport>