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<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>00896984000316</udiDi>
    <basicUdiDi>087448500GuideSleeve83</basicUdiDi>
    <tradeName>Endoscope Light Guide Sleeve - Circon</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06-6019</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:49.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896984000323</udiDi>
    <basicUdiDi>087448500GuideSleeve83</basicUdiDi>
    <tradeName>Endoscope Light Guide Sleeve - Karl Storz</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06-6023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:49.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896984000347</udiDi>
    <basicUdiDi>087448500GuideSleeve83</basicUdiDi>
    <tradeName>Endoscope Light Guide Sleeve - Olympus</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06-6044</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:49.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896984000354</udiDi>
    <basicUdiDi>087448500GuideSleeve83</basicUdiDi>
    <tradeName>Endoscope Light Guide Sleeve - Pentax</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06-6009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:49.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896984000361</udiDi>
    <basicUdiDi>087448500GuideSleeve83</basicUdiDi>
    <tradeName>Endoscope Light Guide Sleeve - Wolf</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06-6020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:49.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874485003609</udiDi>
    <basicUdiDi>087448500EndowipeLB</basicUdiDi>
    <tradeName>EndoWipe Enzymatic Sponge</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12011380</emdnCode>
    <emdnDescription>CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T17:10:32.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874485003494</udiDi>
    <basicUdiDi>087448500UNITYKG</basicUdiDi>
    <tradeName>Unity 9000 Digital Video Processor</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12020406</emdnCode>
    <emdnDescription>VIDEO PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T17:10:31.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874485002480</udiDi>
    <basicUdiDi>087448500GuideCableDE</basicUdiDi>
    <tradeName>Detachable Light Guide Cable, 2.5M</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12020780</emdnCode>
    <emdnDescription>GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T07:52:45.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874485002084</udiDi>
    <basicUdiDi>087448500BLS10008K</basicUdiDi>
    <tradeName>BLS-1000 Light Source Kit, Europe</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12020402</emdnCode>
    <emdnDescription>LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T07:52:44.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874485001605</udiDi>
    <basicUdiDi>087448500CST4000CX</basicUdiDi>
    <tradeName>CST-4000i Series Fiberoptic  Cystoscope/Hysteroscope</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12020701</emdnCode>
    <emdnDescription>CYSTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T07:52:42.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874485001599</udiDi>
    <basicUdiDi>087448500CST4000CX</basicUdiDi>
    <tradeName>CST-4000 Series Fiberoptic Cystoscope/Hysteroscope</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12020704</emdnCode>
    <emdnDescription>HYSTEROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T07:52:41.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874485000349</udiDi>
    <basicUdiDi>087448500GuideCableDE</basicUdiDi>
    <tradeName>Fiberoptic Light Cable</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12020780</emdnCode>
    <emdnDescription>GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T07:52:40.410Z</lastUpdated>
  </row>
</eudamedExport>