<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060768280439</udiDi>
    <basicUdiDi>506076828LUX1EY</basicUdiDi>
    <tradeName>LumenEye X1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SurgEase Innovations Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016541</manufacturerSrn>
    <authorisedRepresentativeName>Advena SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000051131</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LX1-SCP-204</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-29T00:17:08.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060768280392</udiDi>
    <basicUdiDi>506076828LUX1EY</basicUdiDi>
    <tradeName>Docking Case</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SurgEase Innovations Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016541</manufacturerSrn>
    <authorisedRepresentativeName>Advena SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000051131</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LX1-DCK-303</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-28T19:36:21.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060768280484</udiDi>
    <basicUdiDi>506076828LUX1EY</basicUdiDi>
    <tradeName>LumenEye X1 System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SurgEase Innovations Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016541</manufacturerSrn>
    <authorisedRepresentativeName>Advena SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000051131</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LX1-PCK-306</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-28T19:36:19.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060768280231</udiDi>
    <basicUdiDi>506076828LUX1EY</basicUdiDi>
    <tradeName>LumenEye® X1 Consumable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SurgEase Innovations Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016541</manufacturerSrn>
    <authorisedRepresentativeName>Advena SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000051131</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LX1-CSB-201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-28T19:36:11.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060768280040</udiDi>
    <basicUdiDi>506076828LUX1EY</basicUdiDi>
    <tradeName>LumenEye® X1 Consumable with Camera Cover</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SurgEase Innovations Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016541</manufacturerSrn>
    <authorisedRepresentativeName>Advena SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000051131</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LX1-CCS-202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-28T19:36:06.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060768280736</udiDi>
    <basicUdiDi>506076828LUX1EY</basicUdiDi>
    <tradeName>Large LumenEye x1 Manifold -26mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SurgEase Innovations Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016541</manufacturerSrn>
    <authorisedRepresentativeName>Advena SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000051131</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LX1-LMB-261</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-28T19:35:46.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060768280750</udiDi>
    <basicUdiDi>506076828LUX1EY</basicUdiDi>
    <tradeName>Large LumenEye x1 Manifold -30mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SurgEase Innovations Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016541</manufacturerSrn>
    <authorisedRepresentativeName>Advena SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000051131</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LX1-LMB-301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-28T19:35:45.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060768280576</udiDi>
    <basicUdiDi>506076828SESISFS</basicUdiDi>
    <tradeName>SESIS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SurgEase Innovations Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016541</manufacturerSrn>
    <authorisedRepresentativeName>Advena SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000051131</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIS-CSB-101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-28T19:35:30.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060768280491</udiDi>
    <basicUdiDi>506076828TRIEYEM8</basicUdiDi>
    <tradeName>TriEye</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SurgEase Innovations Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016541</manufacturerSrn>
    <authorisedRepresentativeName>Advena SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000051131</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRI-SCP-201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-28T19:35:07.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060768280552</udiDi>
    <basicUdiDi>506076828TRIEYEM8</basicUdiDi>
    <tradeName>Docking Case</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SurgEase Innovations Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016541</manufacturerSrn>
    <authorisedRepresentativeName>Advena SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000051131</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRI-DCK-201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-28T19:34:53.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060768280569</udiDi>
    <basicUdiDi>506076828TRIEYEM8</basicUdiDi>
    <tradeName>TriEye System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SurgEase Innovations Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016541</manufacturerSrn>
    <authorisedRepresentativeName>Advena SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000051131</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRI-PCK-202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-28T19:34:48.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060768280507</udiDi>
    <basicUdiDi>506076828TRIEYEM8</basicUdiDi>
    <tradeName>TriEye® Wide Consumable Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SurgEase Innovations Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016541</manufacturerSrn>
    <authorisedRepresentativeName>Advena SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000051131</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRI-CSB-501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-28T19:34:47.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060768280644</udiDi>
    <basicUdiDi>506076828TRIEYEM8</basicUdiDi>
    <tradeName>TriEye Wide Consumable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SurgEase Innovations Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016541</manufacturerSrn>
    <authorisedRepresentativeName>Advena SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000051131</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRI-WCB-501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-28T19:34:33.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060768280668</udiDi>
    <basicUdiDi>506076828TRIEYEM8</basicUdiDi>
    <tradeName>TriEye Consumable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SurgEase Innovations Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016541</manufacturerSrn>
    <authorisedRepresentativeName>Advena SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000051131</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRI-NCB-501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-28T19:34:32.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060768280682</udiDi>
    <basicUdiDi>506076828TRIEYEM8</basicUdiDi>
    <tradeName>Bellows</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SurgEase Innovations Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016541</manufacturerSrn>
    <authorisedRepresentativeName>Advena SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000051131</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUR-BCB-501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-28T19:34:29.186Z</lastUpdated>
  </row>
</eudamedExport>