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<eudamedExport entity="devices">
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    <udiDi>04056481001438</udiDi>
    <basicUdiDi>B-04056481001438</basicUdiDi>
    <tradeName>Suction MS (CH10) Starlink Frazier</tradeName>
    <deviceName>Cranial/ENT</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55790-65</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:50.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481001421</udiDi>
    <basicUdiDi>B-04056481001421</basicUdiDi>
    <tradeName>Suction STD (CH10) Starlink Frazier</tradeName>
    <deviceName>Cranial/ENT</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55790-70</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:46.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481001414</udiDi>
    <basicUdiDi>B-04056481001414</basicUdiDi>
    <tradeName>Suction STD (CH8) Starlink Frazier</tradeName>
    <deviceName>Cranial/ENT</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55790-75</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:45.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481001407</udiDi>
    <basicUdiDi>B-04056481001407</basicUdiDi>
    <tradeName>Suction STD (CH10) Starlink</tradeName>
    <deviceName>Cranial/ENT</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55790A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:45.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481001391</udiDi>
    <basicUdiDi>B-04056481001391</basicUdiDi>
    <tradeName>Pointer Tip (Offset 0°, length 150 mm)</tradeName>
    <deviceName>Cranial/ENT</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55791-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:44.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481001377</udiDi>
    <basicUdiDi>B-04056481001377</basicUdiDi>
    <tradeName>Pointer Tip (Offset 30°, length 95 mm)</tradeName>
    <deviceName>Cranial/ENT</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55791-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:40.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481001360</udiDi>
    <basicUdiDi>B-04056481001360</basicUdiDi>
    <tradeName>Pointer Tip (Offset 0°, length 100 mm)</tradeName>
    <deviceName>Cranial/ENT</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55791-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:39.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481001353</udiDi>
    <basicUdiDi>B-04056481001353</basicUdiDi>
    <tradeName>Pointer Tip (Offset 0°, length 60 mm)</tradeName>
    <deviceName>Cranial/ENT</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55791-05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:37.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481001346</udiDi>
    <basicUdiDi>B-04056481001346</basicUdiDi>
    <tradeName>Eraser Pointer Tip (Curved)</tradeName>
    <deviceName>Cranial/ENT</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55791-06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:37.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481001339</udiDi>
    <basicUdiDi>B-04056481001339</basicUdiDi>
    <tradeName>Eraser Pointer Tip (Straight)</tradeName>
    <deviceName>Cranial/ENT</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55791-07</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:33.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481001117</udiDi>
    <basicUdiDi>B-04056481001117</basicUdiDi>
    <tradeName>Drill Guide Trocar Tube 5mm X 180mm</tradeName>
    <deviceName>Spine &amp; Trauma 3D Instruments</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55839-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:32.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481001100</udiDi>
    <basicUdiDi>B-04056481001100</basicUdiDi>
    <tradeName>Trocar Reduction Sleeve 2.0mm</tradeName>
    <deviceName>Spine &amp; Trauma 3D Instruments</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55839-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:31.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481001094</udiDi>
    <basicUdiDi>B-04056481001094</basicUdiDi>
    <tradeName>Trocar Reduction Sleeve 2.8mm</tradeName>
    <deviceName>Spine &amp; Trauma 3D Instruments</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55839-28</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:30.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481001087</udiDi>
    <basicUdiDi>B-04056481001087</basicUdiDi>
    <tradeName>Trocar Reduction Sleeve 3.2mm</tradeName>
    <deviceName>Spine &amp; Trauma 3D Instruments</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55839-32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:26.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481001070</udiDi>
    <basicUdiDi>B-04056481001070</basicUdiDi>
    <tradeName>Drill Guide Tissue Protection Sleeve 10mm</tradeName>
    <deviceName>Spine &amp; Trauma 3D Instruments</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55839-40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:25.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056481001056</udiDi>
    <basicUdiDi>B-04056481001056</basicUdiDi>
    <tradeName>Trocar Insert 5mm</tradeName>
    <deviceName>Trocar Insert 5mm</deviceName>
    <manufacturerName>Brainlab SE</manufacturerName>
    <manufacturerSrn>DE-MF-000006183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55839-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:26:25.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052141890110</udiDi>
    <basicUdiDi>8052141890004SIR0JG</basicUdiDi>
    <tradeName>Needle fiducial - Sensor IR</tradeName>
    <deviceName>Needle fiducial - Sensor IR</deviceName>
    <manufacturerName>R.A.W. Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027589</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIR000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:15:23.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052141890103</udiDi>
    <basicUdiDi>8052141890004SU00H9</basicUdiDi>
    <tradeName>Needle fiducial - Sensor U</tradeName>
    <deviceName>Needle fiducial - Sensor U</deviceName>
    <manufacturerName>R.A.W. Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027589</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SU000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:15:22.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052141890097</udiDi>
    <basicUdiDi>8052141890004MIR0H6</basicUdiDi>
    <tradeName>Patient fiducial - Marker IR</tradeName>
    <deviceName>Patient fiducial - Marker IR</deviceName>
    <manufacturerName>R.A.W. Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027589</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIR000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:15:21.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052141890080</udiDi>
    <basicUdiDi>8052141890004MK00ED</basicUdiDi>
    <tradeName>Patient fiducial - Marker kit</tradeName>
    <deviceName>Patient fiducial - Marker kit</deviceName>
    <manufacturerName>R.A.W. Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027589</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011480</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MK000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:15:16.615Z</lastUpdated>
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</eudamedExport>