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<eudamedExport entity="devices">
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    <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>2026-08-01T17:45:32.371Z</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>2026-08-01T17:45:30.775Z</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>2026-08-01T17:45:29.971Z</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>2026-08-01T17:45:28.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159002362</udiDi>
    <basicUdiDi>B-00846159002362</basicUdiDi>
    <tradeName>00846159002362</tradeName>
    <deviceName>Scanlan SUTURE-STATT® suture tags</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030101</emdnCode>
    <emdnDescription>COVER CAPS, INSTRUMENTS AND EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-520</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:19.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159002355</udiDi>
    <basicUdiDi>B-00846159002355</basicUdiDi>
    <tradeName>00846159002355</tradeName>
    <deviceName>Scanlan PINCAP® orthopedic pin protectors</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030101</emdnCode>
    <emdnDescription>COVER CAPS, INSTRUMENTS AND EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301-0130</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:19.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159002348</udiDi>
    <basicUdiDi>B-00846159002348</basicUdiDi>
    <tradeName>00846159002348</tradeName>
    <deviceName>Scanlan PINCAP® orthopedic pin protectors</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030101</emdnCode>
    <emdnDescription>COVER CAPS, INSTRUMENTS AND EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301-0120</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:18.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159002331</udiDi>
    <basicUdiDi>B-00846159002331</basicUdiDi>
    <tradeName>00846159002331</tradeName>
    <deviceName>Scanlan PINCAP® orthopedic pin protectors</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030101</emdnCode>
    <emdnDescription>COVER CAPS, INSTRUMENTS AND EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301-0110</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:14.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>00845225012700</udiDi>
    <basicUdiDi>B-00845225012700</basicUdiDi>
    <tradeName>R-100 Sterile Equipment Cover</tradeName>
    <deviceName>Sterile Drapes</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PBKBG</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:12.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>00845225012694</udiDi>
    <basicUdiDi>B-00845225012694</basicUdiDi>
    <tradeName>Digital IVUS Sterile Equipment Cover</tradeName>
    <deviceName>Sterile Drapes</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5902VC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:11.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>00845225012687</udiDi>
    <basicUdiDi>B-00845225012687</basicUdiDi>
    <tradeName>SpinVision Sterile Equipment Cover</tradeName>
    <deviceName>Sterile Drapes</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>891BG</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:07.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G086703111</udiDi>
    <basicUdiDi>++G086HygieneSleevesLC</basicUdiDi>
    <tradeName>Universal-Cameraschutzhüllen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>M. G. Kurth GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000045501</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70311</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T01:40:20.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G086703141</udiDi>
    <basicUdiDi>++G086HygieneSleevesLC</basicUdiDi>
    <tradeName>Hygiene-Schutzhüllen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>M. G. Kurth GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000045501</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>703014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T01:40:20.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G086703151</udiDi>
    <basicUdiDi>++G086HygieneSleevesLC</basicUdiDi>
    <tradeName>Hygiene-Schutzhüllen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>M. G. Kurth GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000045501</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70315</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T01:40:20.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G086703251</udiDi>
    <basicUdiDi>++G086HygieneSleevesLC</basicUdiDi>
    <tradeName>Sensor Schutzhüllen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>M. G. Kurth GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000045501</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70325</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T01:40:20.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G086703301</udiDi>
    <basicUdiDi>++G086HygieneSleevesLC</basicUdiDi>
    <tradeName>Hygiene-Schutzhüllen für Aufbiss</tradeName>
    <deviceName></deviceName>
    <manufacturerName>M. G. Kurth GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000045501</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70330</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T01:40:20.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G08670401</udiDi>
    <basicUdiDi>++G086ScanSleevesLJ</basicUdiDi>
    <tradeName>++G08670401</tradeName>
    <deviceName></deviceName>
    <manufacturerName>M. G. Kurth GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000045501</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T01:40:20.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G086704021</udiDi>
    <basicUdiDi>++G086ScanSleevesLJ</basicUdiDi>
    <tradeName>Speicherfolien Schutzhülle Trend Line</tradeName>
    <deviceName></deviceName>
    <manufacturerName>M. G. Kurth GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000045501</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70402</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T01:40:20.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G086704031</udiDi>
    <basicUdiDi>++G086ScanSleevesLJ</basicUdiDi>
    <tradeName>Speicherfolien-Schutzhülle Trend Line</tradeName>
    <deviceName></deviceName>
    <manufacturerName>M. G. Kurth GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000045501</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70403</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T01:40:20.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G086704041</udiDi>
    <basicUdiDi>++G086ScanSleevesLJ</basicUdiDi>
    <tradeName>Speicherfolien Schutzhüllen Trend-Line</tradeName>
    <deviceName></deviceName>
    <manufacturerName>M. G. Kurth GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000045501</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70404</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T01:40:20.386Z</lastUpdated>
  </row>
</eudamedExport>