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<eudamedExport entity="devices">
  <row>
    <udiDi>00858015005998</udiDi>
    <basicUdiDi>B-00858015005998</basicUdiDi>
    <tradeName>BiomarC PRO Fiducial Marker</tradeName>
    <deviceName>BiomarC Carbon Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040149</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:55.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858015005981</udiDi>
    <basicUdiDi>B-00858015005981</basicUdiDi>
    <tradeName>BiomarC PRO Fiducial Marker</tradeName>
    <deviceName>BiomarC Carbon Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040148</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:53.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852588007236</udiDi>
    <basicUdiDi>B-00852588007236</basicUdiDi>
    <tradeName>Insuflow Port 5mm Bariatric</tradeName>
    <deviceName>Insuflow Port 5mm Bariatric</deviceName>
    <manufacturerName>Lexion Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000033626</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4100-5B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:43.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852588007229</udiDi>
    <basicUdiDi>B-00852588007229</basicUdiDi>
    <tradeName>AP50/30 High-Flow Insufflator</tradeName>
    <deviceName>AP50/30 High Flow Insufflator</deviceName>
    <manufacturerName>Lexion Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000033626</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12029008</emdnCode>
    <emdnDescription>GAS INFLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:42.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852588007212</udiDi>
    <basicUdiDi>B-00852588007212</basicUdiDi>
    <tradeName>Insuflow Port 12mm Bariatric</tradeName>
    <deviceName>Insuflow Port 12mm Bariatric</deviceName>
    <manufacturerName>Lexion Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000033626</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4100-12B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:41.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852588007205</udiDi>
    <basicUdiDi>B-00852588007205</basicUdiDi>
    <tradeName>Insuflow Port 12mm</tradeName>
    <deviceName>Insuflow Port 12mm</deviceName>
    <manufacturerName>Lexion Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000033626</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4100-12</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:38.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852588007199</udiDi>
    <basicUdiDi>B-00852588007199</basicUdiDi>
    <tradeName>Insuflow Port 10mm Bariatric</tradeName>
    <deviceName>Insuflow Port 10mm Bariatric</deviceName>
    <manufacturerName>Lexion Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000033626</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4100-10B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:37.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852588007182</udiDi>
    <basicUdiDi>B-00852588007182</basicUdiDi>
    <tradeName>Insuflow Port 10mm</tradeName>
    <deviceName>Insuflow Port 10mm</deviceName>
    <manufacturerName>Lexion Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000033626</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4100-10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:36.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852588007175</udiDi>
    <basicUdiDi>B-00852588007175</basicUdiDi>
    <tradeName>Insuflow Port 8mm Bariatric</tradeName>
    <deviceName>Insuflow Port 8mm Bariatric</deviceName>
    <manufacturerName>Lexion Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000033626</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4100-8B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:34.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852588007168</udiDi>
    <basicUdiDi>B-00852588007168</basicUdiDi>
    <tradeName>Insuflow Port 8mm</tradeName>
    <deviceName>Insuflow Port 8mm</deviceName>
    <manufacturerName>Lexion Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000033626</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4100-8</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:32.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852588007151</udiDi>
    <basicUdiDi>B-00852588007151</basicUdiDi>
    <tradeName>Insuflow Port 5mm</tradeName>
    <deviceName>Insuflow Port 5mm</deviceName>
    <manufacturerName>Lexion Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000033626</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4100-5</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:30.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852588007045</udiDi>
    <basicUdiDi>B-00852588007045</basicUdiDi>
    <tradeName>PneuView XE</tradeName>
    <deviceName>PneuView XE</deviceName>
    <manufacturerName>Lexion Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000033626</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02010107</emdnCode>
    <emdnDescription>SMOKE EVACUATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9660-XE</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:29.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850002461107</udiDi>
    <basicUdiDi>B-00850002461107</basicUdiDi>
    <tradeName>BiomarC Restore Fiducial Marker</tradeName>
    <deviceName>BiomarC Restore Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040156</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:12.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850002461091</udiDi>
    <basicUdiDi>B-00850002461091</basicUdiDi>
    <tradeName>BiomarC Restore Fiducial Marker</tradeName>
    <deviceName>BiomarC Restore Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040155</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:10.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>09358996000018</udiDi>
    <basicUdiDi>9358996000001D9</basicUdiDi>
    <tradeName>Zed Link</tradeName>
    <deviceName>Zed Link</deviceName>
    <manufacturerName>Zed Technologies Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000034171</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZEDLINK</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:08:20.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>09337363001247</udiDi>
    <basicUdiDi>93373630QSBRFL00001PQ</basicUdiDi>
    <tradeName>Qlicksmart BladeFLASK</tradeName>
    <deviceName>Qlicksmart Scalpel Blade Remover</deviceName>
    <manufacturerName>Qlicksmart Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033870</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QFYGEN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:04:36.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>09337363000516</udiDi>
    <basicUdiDi>93373630QSBRSNS0000149</basicUdiDi>
    <tradeName>BladeCASSETTE Non sterile Scalpel Blade Remover</tradeName>
    <deviceName>Qlicksmart Single Use Scalpel Blade Removers Non-Sterile</deviceName>
    <manufacturerName>Qlicksmart Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033870</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QSSVCAS-BY</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:04:32.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970229252075</udiDi>
    <basicUdiDi>697022925GCE8XXEM</basicUdiDi>
    <tradeName>SIH 09</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Globalcare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033595</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>854.71</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:48:11.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970229252884</udiDi>
    <basicUdiDi>697022925GCE8XXEM</basicUdiDi>
    <tradeName>SIH 09</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Globalcare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033595</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>854.72</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:48:10.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970229252099</udiDi>
    <basicUdiDi>697022925GCE8XXEM</basicUdiDi>
    <tradeName>SIH 09</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Globalcare Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033595</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>854.74</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:48:10.852Z</lastUpdated>
  </row>
</eudamedExport>