<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>EPRCA0011000</udiDi>
    <basicUdiDi>++EPRC12140102BC</basicUdiDi>
    <tradeName>otosil PS-1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0011000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:46:23.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA0034160</udiDi>
    <basicUdiDi>++EPRC12140103BE</basicUdiDi>
    <tradeName>otosil SL-1 | MSI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0034160</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:46:20.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA0034151</udiDi>
    <basicUdiDi>++EPRC12140103BE</basicUdiDi>
    <tradeName>otosil SL-1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0034151</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:46:20.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360453</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>NasalSpec</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>ENT SPECULUMS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NasalSpec-L(5)</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360460</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>NasalSpec</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>ENT SPECULUMS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NasalSpec-XM(4)</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360477</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>NasalSpec</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>ENT SPECULUMS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NasalSpec-M(3)</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360484</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>NasalSpec</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>ENT SPECULUMS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NasalSpec-S(2)</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360491</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>NasalSpec</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>ENT SPECULUMS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NasalSpec-Mini(1)</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360507</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>EosTips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosTips</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360514</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>EosCurette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>ENT SURGERY CURETTES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosCurette-Ring</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360521</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>EosCurette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>ENT SURGERY CURETTES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosCurette-Spoon</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360538</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>EosOtoSpec I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosOtoSpec I(Keeler)-4.5mm</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360545</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>EosOtoSpec I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosOtoSpec I(Keeler)-3.5mm</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360552</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>EosOtoSpecI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosOtoSpec I(Keeler)-2.5mm</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360569</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>EosOtoSpec I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosOtoSpec I(Keeler)-5.5mm</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360576</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>EosCups</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosCups</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360583</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>EosOtoSpec II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosOtoSpec II (W.A.)-4.25mm</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360590</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>EosOtoSpec II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosOtoSpec II(W.A.)-2.75mm</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360620</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>EosAdaptor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosAdaptor</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360781</udiDi>
    <basicUdiDi>471256836ENTKV</basicUdiDi>
    <tradeName>EosOtoSpec III</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORTH EOS INDUSTRIES,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000007743</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosOtoSpec III(Heine)-larger-2.5mm</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.365Z</lastUpdated>
  </row>
</eudamedExport>