<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850019946468</udiDi>
    <basicUdiDi>0850019946EXRADINDIODEAY</basicUdiDi>
    <tradeName>Exradin D1V Diode</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92740</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946475</udiDi>
    <basicUdiDi>0850019946EXRADINDIODEAY</basicUdiDi>
    <tradeName>Exradin D1H Diode</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92741</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946482</udiDi>
    <basicUdiDi>0850019946EXRADINSCINTIQF</basicUdiDi>
    <tradeName>Exradin W1 Scintillator</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92739</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946499</udiDi>
    <basicUdiDi>0850019946WATERTANKU9</basicUdiDi>
    <tradeName>TomoScanner</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91750</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946505</udiDi>
    <basicUdiDi>0850019946LUCYPHANTOMP4</basicUdiDi>
    <tradeName>LUCY 3D QA Phantom</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91210</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946512</udiDi>
    <basicUdiDi>0850019946MIMIPHANTOMAV</basicUdiDi>
    <tradeName>MIMI Phantom</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91240</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946529</udiDi>
    <basicUdiDi>0850019946SDVPHANTOMNS</basicUdiDi>
    <tradeName>Stereotactic Dose Verification Phantom</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946536</udiDi>
    <basicUdiDi>0850019946WLUTZPHANTOMMC</basicUdiDi>
    <tradeName>Winston Lutz Cube Phantom</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91345</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946543</udiDi>
    <basicUdiDi>08665620002IMSURE8S</basicUdiDi>
    <tradeName>IMSure 3D</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91365</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946550</udiDi>
    <basicUdiDi>0850019946IMRTPHANTOMLR</basicUdiDi>
    <tradeName>IMRT Phantom</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91230</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946567</udiDi>
    <basicUdiDi>0850019946RECONJIGXH</basicUdiDi>
    <tradeName>Reconstruction Jig (Large)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91280</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946574</udiDi>
    <basicUdiDi>0850019946RECONJIGXH</basicUdiDi>
    <tradeName>Reconstruction Jig (Small)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91285</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946581</udiDi>
    <basicUdiDi>0850019946EXRADINICL5</basicUdiDi>
    <tradeName>Exradin A10</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92702</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946598</udiDi>
    <basicUdiDi>0850019946EXRADINICL5</basicUdiDi>
    <tradeName>Exradin P11</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92703</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946604</udiDi>
    <basicUdiDi>08665620002IMSURE8S</basicUdiDi>
    <tradeName>IMSure</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>91355</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946611</udiDi>
    <basicUdiDi>0850019946SEEDPOUCHKH</basicUdiDi>
    <tradeName>Protective Lead Seed Pouch</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946628</udiDi>
    <basicUdiDi>0850019946ELECTROMETER7L</basicUdiDi>
    <tradeName>MAX Elite Electrometer</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946635</udiDi>
    <basicUdiDi>0850019946LUCYPHANTOMP4</basicUdiDi>
    <tradeName>LUCY EA Phantom</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946642</udiDi>
    <basicUdiDi>08665620002DOSEVIEWZD</basicUdiDi>
    <tradeName>DoseView 3D Helical</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850019946659</udiDi>
    <basicUdiDi>0850019946LUCYPHANTOMP4</basicUdiDi>
    <tradeName>LUCY ThorX Phantom</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91630</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:13.515Z</lastUpdated>
  </row>
</eudamedExport>