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<eudamedExport entity="devices">
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    <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>
</eudamedExport>