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    <udiDi>05060494200169</udiDi>
    <basicUdiDi>B-05060494200169</basicUdiDi>
    <tradeName>Xstrahl XBeam Standalone Software v1.5.5</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>Z11019082</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XS8815</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-19T15:27:37.112Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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  <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>
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    <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>
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  <row>
    <udiDi>07350002011065</udiDi>
    <basicUdiDi>73500020106HJ</basicUdiDi>
    <tradeName>RayCare v2026</tradeName>
    <deviceName>RayCare</deviceName>
    <manufacturerName>RAYSEARCH LABORATORIES AB (PUBL)</manufacturerName>
    <manufacturerSrn>SE-MF-000001908</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019082</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10.0</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:35:49.489Z</lastUpdated>
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  <row>
    <udiDi>07350002010990</udiDi>
    <basicUdiDi>73500020106HJ</basicUdiDi>
    <tradeName>RayCare v2025 SP-Probeat</tradeName>
    <deviceName>RayCare</deviceName>
    <manufacturerName>RAYSEARCH LABORATORIES AB (PUBL)</manufacturerName>
    <manufacturerSrn>SE-MF-000001908</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11019082</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>9.2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:37:39.923Z</lastUpdated>
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  <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <udiDi>00850019946130</udiDi>
    <basicUdiDi>0850019946EXRADINICL5</basicUdiDi>
    <tradeName>Exradin Magna 1cc</tradeName>
    <deviceName>Exradin Ion 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>Z11019082</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92600</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:19:06.850Z</lastUpdated>
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