<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060608880348</udiDi>
    <basicUdiDi>506060888SWSunCHECKTS</basicUdiDi>
    <tradeName>SunCHECK</tradeName>
    <deviceName>SunCHECK</deviceName>
    <manufacturerName>Sun Nuclear Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020245</manufacturerSrn>
    <authorisedRepresentativeName>Sun Nuclear GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012933</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010192</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1299</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:24:37.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060608880188</udiDi>
    <basicUdiDi>506060888DASRSMPCHECK5V</basicUdiDi>
    <tradeName>SRS MapCHECK</tradeName>
    <deviceName>SRS MapCHECK</deviceName>
    <manufacturerName>Sun Nuclear Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020245</manufacturerSrn>
    <authorisedRepresentativeName>Sun Nuclear GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012933</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010180</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1179</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:24:37.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060608880133</udiDi>
    <basicUdiDi>506060888DPSNC600cAH</basicUdiDi>
    <tradeName>SNC600c</tradeName>
    <deviceName>SNC600c</deviceName>
    <manufacturerName>Sun Nuclear Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020245</manufacturerSrn>
    <authorisedRepresentativeName>Sun Nuclear GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012933</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010180</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1047</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:24:36.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060608880126</udiDi>
    <basicUdiDi>506060888DPSNC350pBF</basicUdiDi>
    <tradeName>SNC350p</tradeName>
    <deviceName>SNC350p</deviceName>
    <manufacturerName>Sun Nuclear Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020245</manufacturerSrn>
    <authorisedRepresentativeName>Sun Nuclear GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012933</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010180</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:24:35.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060608880119</udiDi>
    <basicUdiDi>506060888DPSNC125cA7</basicUdiDi>
    <tradeName>SNC125c</tradeName>
    <deviceName>SNC125c</deviceName>
    <manufacturerName>Sun Nuclear Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020245</manufacturerSrn>
    <authorisedRepresentativeName>Sun Nuclear GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012933</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010180</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:24:34.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060608880096</udiDi>
    <basicUdiDi>506060888WT1DSCANNER3V</basicUdiDi>
    <tradeName>1D Scanner</tradeName>
    <deviceName>1D Scanner</deviceName>
    <manufacturerName>Sun Nuclear Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020245</manufacturerSrn>
    <authorisedRepresentativeName>Sun Nuclear GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012933</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010180</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1233</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:24:33.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060608880072</udiDi>
    <basicUdiDi>506060888DPEdgeDTD</basicUdiDi>
    <tradeName>Edge Detector (BNC)</tradeName>
    <deviceName>Edge Detector</deviceName>
    <manufacturerName>Sun Nuclear Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020245</manufacturerSrn>
    <authorisedRepresentativeName>Sun Nuclear GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012933</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010180</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1118</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:24:33.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060608880065</udiDi>
    <basicUdiDi>506060888DPPCElec6N</basicUdiDi>
    <tradeName>PC Electrometer</tradeName>
    <deviceName>PC Electrometer</deviceName>
    <manufacturerName>Sun Nuclear Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020245</manufacturerSrn>
    <authorisedRepresentativeName>Sun Nuclear GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012933</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010180</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:24:32.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060608880034</udiDi>
    <basicUdiDi>506060888DADailyQA3WY</basicUdiDi>
    <tradeName>Daily QA 3</tradeName>
    <deviceName>Daily QA 3</deviceName>
    <manufacturerName>Sun Nuclear Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020245</manufacturerSrn>
    <authorisedRepresentativeName>Sun Nuclear GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012933</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010180</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1093</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:24:31.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060608880027</udiDi>
    <basicUdiDi>506060888DAArcCHECKDJ</basicUdiDi>
    <tradeName>ArcCHECK</tradeName>
    <deviceName>ArcCHECK</deviceName>
    <manufacturerName>Sun Nuclear Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020245</manufacturerSrn>
    <authorisedRepresentativeName>Sun Nuclear GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012933</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010180</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:24:30.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060608880003</udiDi>
    <basicUdiDi>506060888DAMPCHECK3S9</basicUdiDi>
    <tradeName>MapCHECK 3</tradeName>
    <deviceName>MapCHECK 3</deviceName>
    <manufacturerName>Sun Nuclear Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020245</manufacturerSrn>
    <authorisedRepresentativeName>Sun Nuclear GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012933</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010180</emdnCode>
    <emdnDescription>LINEAR ACCELERATORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1178</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:24:30.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719879740028</udiDi>
    <basicUdiDi>471987974RT58</basicUdiDi>
    <tradeName>Conformal Bolus-Transparent</tradeName>
    <deviceName>Radiological Positioning Holders, Cradles and Accessories</deviceName>
    <manufacturerName>Blessing Cathay Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000033419</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>CBT-0.2x30 (BTP-0.2x30)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:20:07.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481144494</udiDi>
    <basicUdiDi>4056481RTElementsW8</basicUdiDi>
    <tradeName>RT Elements, 4.0</tradeName>
    <deviceName>RT Elements</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010492</emdnCode>
    <emdnDescription>RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04056481144494</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:34:12.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481143978</udiDi>
    <basicUdiDi>4056481ExacTracEU</basicUdiDi>
    <tradeName>ExacTrac Dynamic, 1.1</tradeName>
    <deviceName>ExacTrac Dynamic</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</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>Artık piyasada değil</deviceStatus>
    <reference>48519A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:34:04.181Z</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>
  <row>
    <udiDi>04056481144180</udiDi>
    <basicUdiDi>4056481Cranial4PiHeadShJ4</basicUdiDi>
    <tradeName>Cranial 4PI Headrest Inlay H&amp;N 2Pcs</tradeName>
    <deviceName>Cranial 4PI Headrest Inlays</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>43448A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:30:16.840Z</lastUpdated>
  </row>
</eudamedExport>