<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04712568360323</udiDi>
    <basicUdiDi>471256836URONF</basicUdiDi>
    <tradeName>ProctoSpec 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>G02060302</emdnCode>
    <emdnDescription>ANOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ProctoSpec I-M</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360330</udiDi>
    <basicUdiDi>471256836URONF</basicUdiDi>
    <tradeName>ProctoSpec 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>G02060302</emdnCode>
    <emdnDescription>ANOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ProctoSpec I-S</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360347</udiDi>
    <basicUdiDi>471256836URONF</basicUdiDi>
    <tradeName>ProctoSpec 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>G02060302</emdnCode>
    <emdnDescription>ANOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ProctoSpec I-Mini</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360613</udiDi>
    <basicUdiDi>471256836URONF</basicUdiDi>
    <tradeName>ProctoSpec 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>G02060302</emdnCode>
    <emdnDescription>ANOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ProctoSpec II+EosPusher</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360637</udiDi>
    <basicUdiDi>471256836URONF</basicUdiDi>
    <tradeName>ProctoSpec 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>G02060302</emdnCode>
    <emdnDescription>ANOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ProctoSpec III-M</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360682</udiDi>
    <basicUdiDi>471256836URONF</basicUdiDi>
    <tradeName>ProctoSpec 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>G02060302</emdnCode>
    <emdnDescription>ANOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ProctoSpec III-L</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360699</udiDi>
    <basicUdiDi>471256836URONF</basicUdiDi>
    <tradeName>ProctoSpec IV</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>G02060302</emdnCode>
    <emdnDescription>ANOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ProctoSpec IV-M</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360705</udiDi>
    <basicUdiDi>471256836URONF</basicUdiDi>
    <tradeName>EosSigmoidoSpec</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>G02060302</emdnCode>
    <emdnDescription>SIGMOIDOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosSigmoidoSpec-25CM(with short inner sleeve)</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360729</udiDi>
    <basicUdiDi>471256836URONF</basicUdiDi>
    <tradeName>EosSigmoidoSpec</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>G02060302</emdnCode>
    <emdnDescription>SIGMOIDOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosSigmoidoSpec-25CM(without short inner sleeve)</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360736</udiDi>
    <basicUdiDi>471256836URONF</basicUdiDi>
    <tradeName>ProctoSpec V</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>G02060302</emdnCode>
    <emdnDescription>ANOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ProctoSpec V-(B)-M</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360743</udiDi>
    <basicUdiDi>471256836URONF</basicUdiDi>
    <tradeName>ProctoSpec V</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>G02060302</emdnCode>
    <emdnDescription>ANOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ProctoSpec V-(A)-M</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360750</udiDi>
    <basicUdiDi>471256836URONF</basicUdiDi>
    <tradeName>EosSigmoidoSpec</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>G02060302</emdnCode>
    <emdnDescription>SIGMOIDOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosSigmoidoSpec-20CM</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712568360767</udiDi>
    <basicUdiDi>471256836URONF</basicUdiDi>
    <tradeName>EosSigmoidoSpec</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>G02060302</emdnCode>
    <emdnDescription>SIGMOIDOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EosSigmoidoSpec-for kid</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:06:37.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933298299044</udiDi>
    <basicUdiDi>69332982033VH</basicUdiDi>
    <tradeName>06933298299044</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Suyun Medical Materials Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021132</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060399</emdnCode>
    <emdnDescription>DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:13:53.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933298299037</udiDi>
    <basicUdiDi>69332982033VH</basicUdiDi>
    <tradeName>06933298299037</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Suyun Medical Materials Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021132</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060399</emdnCode>
    <emdnDescription>DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:13:52.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933298299020</udiDi>
    <basicUdiDi>69332982033VH</basicUdiDi>
    <tradeName>06933298299020</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Suyun Medical Materials Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021132</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060399</emdnCode>
    <emdnDescription>DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:13:51.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933298299013</udiDi>
    <basicUdiDi>69332982033VH</basicUdiDi>
    <tradeName>Sterile Proctoscope for single use</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Suyun Medical Materials Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021132</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060399</emdnCode>
    <emdnDescription>DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Type:II  Size:Medium(22#)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:13:48.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933298297804</udiDi>
    <basicUdiDi>69332982033VH</basicUdiDi>
    <tradeName>06933298297804</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Suyun Medical Materials Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021132</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060399</emdnCode>
    <emdnDescription>DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:12:15.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933298297798</udiDi>
    <basicUdiDi>69332982033VH</basicUdiDi>
    <tradeName>06933298297798</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Suyun Medical Materials Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021132</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02060399</emdnCode>
    <emdnDescription>DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:12:15.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033638800126</udiDi>
    <basicUdiDi>803363880ANSCPSTPK</basicUdiDi>
    <tradeName>THE BEAK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAPI MED S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000023733</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G02060301</emdnCode>
    <emdnDescription>ANOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A.4083</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T22:34:27.080Z</lastUpdated>
  </row>
</eudamedExport>