<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00874485003173</udiDi>
    <basicUdiDi>B-00874485003173</basicUdiDi>
    <tradeName>EndoSheath Protective Barrier</tradeName>
    <deviceName>EndoSheath Protective Barrier</deviceName>
    <manufacturerName>Cogentix Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV 1.5</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:50:05.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874485003166</udiDi>
    <basicUdiDi>B-00874485003166</basicUdiDi>
    <tradeName>EndoSheath Protective Barrier</tradeName>
    <deviceName>EndoSheath Protective Barrier</deviceName>
    <manufacturerName>Cogentix Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV 2.1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:50:03.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874485003159</udiDi>
    <basicUdiDi>B-00874485003159</basicUdiDi>
    <tradeName>EndoSheath Protective Barrier</tradeName>
    <deviceName>EndoSheath Protective Barrier</deviceName>
    <manufacturerName>Cogentix Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF 1.5</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:50:01.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874485003142</udiDi>
    <basicUdiDi>B-00874485003142</basicUdiDi>
    <tradeName>EndoSheath Protective Barrier</tradeName>
    <deviceName>EndoSheath Protective Barrier</deviceName>
    <manufacturerName>Cogentix Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF 2.1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:50:00.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874485001278</udiDi>
    <basicUdiDi>B-00874485001278</basicUdiDi>
    <tradeName>CST-5000i Series Video Cystoscope/Hysteroscope, NTSC</tradeName>
    <deviceName>CST-5000i Series Video Cystoscope/Hysteroscope, NTSC</deviceName>
    <manufacturerName>Cogentix Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020711</emdnCode>
    <emdnDescription>VIDEO CYSTOURETHROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08-5203</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:59.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874485001261</udiDi>
    <basicUdiDi>B-00874485001261</basicUdiDi>
    <tradeName>CST-5000i Series Video Cystoscope/Hysteroscope, PAL</tradeName>
    <deviceName>CST-5000i Series Video Cystoscope/Hysteroscope, PAL</deviceName>
    <manufacturerName>Cogentix Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020711</emdnCode>
    <emdnDescription>VIDEO CYSTOURETHROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08-5204</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:56.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874485000882</udiDi>
    <basicUdiDi>B-00874485000882</basicUdiDi>
    <tradeName>CST-5000 Series Video Cystoscope/Hysteroscope, NTSC</tradeName>
    <deviceName>CST-5000 Series Video Cystoscope/Hysteroscope, NTSC</deviceName>
    <manufacturerName>Cogentix Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020711</emdnCode>
    <emdnDescription>VIDEO CYSTOURETHROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08-5201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:55.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874485000875</udiDi>
    <basicUdiDi>B-00874485000875</basicUdiDi>
    <tradeName>CST-5000 Series Video Cystoscope/Hysteroscope, PAL</tradeName>
    <deviceName>CST-5000 Series Video Cystoscope/Hysteroscope, PAL</deviceName>
    <manufacturerName>Cogentix Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020711</emdnCode>
    <emdnDescription>VIDEO CYSTOURETHROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08-5202</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:54.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627825003759</udiDi>
    <basicUdiDi>B-00627825003759</basicUdiDi>
    <tradeName>Aquarius Urodynamic Analyzer System</tradeName>
    <deviceName>Aquarius Urodynamic Analyzer System</deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12160401</emdnCode>
    <emdnDescription>URODYNAMICS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQS3003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:21.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627825003742</udiDi>
    <basicUdiDi>B-00627825003742</basicUdiDi>
    <tradeName>Aquarius Urodynamic Analyzer System</tradeName>
    <deviceName>Aquarius Urodynamic Analyzer System</deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12160401</emdnCode>
    <emdnDescription>URODYNAMICS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQS3002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:19.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627825003735</udiDi>
    <basicUdiDi>B-00627825003735</basicUdiDi>
    <tradeName>Aquarius Urodynamic Analyzer System</tradeName>
    <deviceName>Aquarius Urodynamic Analyzer System</deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12160401</emdnCode>
    <emdnDescription>URODYNAMICS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQS3001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:17.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627825003728</udiDi>
    <basicUdiDi>B-00627825003728</basicUdiDi>
    <tradeName>Aquarius Urodynamic Analyzer System</tradeName>
    <deviceName>Aquarius Urodynamic Analyzer System</deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12160401</emdnCode>
    <emdnDescription>URODYNAMICS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQS3000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:15.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627825003711</udiDi>
    <basicUdiDi>B-00627825003711</basicUdiDi>
    <tradeName>Aquarius Urodynamic Analyzer System</tradeName>
    <deviceName>Aquarius Urodynamic Analyzer System</deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12160401</emdnCode>
    <emdnDescription>URODYNAMICS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQS2004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:14.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627825003704</udiDi>
    <basicUdiDi>B-00627825003704</basicUdiDi>
    <tradeName>Aquarius Urodynamic Analyzer System</tradeName>
    <deviceName>Aquarius Urodynamics Analyzer System</deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12160401</emdnCode>
    <emdnDescription>URODYNAMICS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQS2002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:13.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627825003575</udiDi>
    <basicUdiDi>B-00627825003575</basicUdiDi>
    <tradeName>Goby Urodynamics Analyzer System</tradeName>
    <deviceName>Goby Urodynamics Analyzer System</deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12160401</emdnCode>
    <emdnDescription>URODYNAMICS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBS007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:10.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627825003568</udiDi>
    <basicUdiDi>B-00627825003568</basicUdiDi>
    <tradeName>GOBY Urodynamic Analyzer System</tradeName>
    <deviceName>Goby UDS System (240V)</deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12160401</emdnCode>
    <emdnDescription>URODYNAMICS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBS006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:09.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627825003551</udiDi>
    <basicUdiDi>B-00627825003551</basicUdiDi>
    <tradeName>GOBY Urodynamic Analyzer System</tradeName>
    <deviceName>GBS005</deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12160401</emdnCode>
    <emdnDescription>URODYNAMICS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBS005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:08.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627825003544</udiDi>
    <basicUdiDi>B-00627825003544</basicUdiDi>
    <tradeName>Aquarius Urodynamics Analyzer System</tradeName>
    <deviceName>Aquarius Urodynamics Analyzer System</deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12160401</emdnCode>
    <emdnDescription>URODYNAMICS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQS2001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:06.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627825003537</udiDi>
    <basicUdiDi>B-00627825003537</basicUdiDi>
    <tradeName>Aquarius Urodynamics Analyzer System</tradeName>
    <deviceName>Aquarius Urodynamics Analyzer System</deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12160401</emdnCode>
    <emdnDescription>URODYNAMICS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQS2000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:04.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627825003520</udiDi>
    <basicUdiDi>B-00627825003520</basicUdiDi>
    <tradeName>Aquarius Urodynamics System</tradeName>
    <deviceName>Aquarius Urodynamic System</deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12160401</emdnCode>
    <emdnDescription>URODYNAMICS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQS1001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:02.966Z</lastUpdated>
  </row>
</eudamedExport>