<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-80340SHEATHESH9</udiDi>
    <basicUdiDi>B-80340SHEATHESH9</basicUdiDi>
    <tradeName>D-80340SHEATHESH9</tradeName>
    <deviceName>Sterile, Specialty Ultrasound Probe Cover with 2 Elastics, Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80340</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:52.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-80040SHEATHESEC</udiDi>
    <basicUdiDi>B-80040SHEATHESEC</basicUdiDi>
    <tradeName>D-80040SHEATHESEC</tradeName>
    <deviceName>Sterile, Specialty Ultrasound Probe Cover with 2 Elastics, Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:29:31.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-75440SHEATHESNQ</udiDi>
    <basicUdiDi>B-75440SHEATHESNQ</basicUdiDi>
    <tradeName>D-75440SHEATHESNQ</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 3" Debris Shield and 1 Elastic, Vaginal/Rectal, Straight, Bi-Directionally Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>75440</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:29.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-75340SHEATHESMR</udiDi>
    <basicUdiDi>B-75340SHEATHESMR</basicUdiDi>
    <tradeName>D-75340SHEATHESMR</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Straight, Narrow, Rolled, Extra-Long</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>75340</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:28.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-40040SHEATHES98</udiDi>
    <basicUdiDi>B-40040SHEATHES98</basicUdiDi>
    <tradeName>D-40040SHEATHES98</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 3" Debris Shield and 1 Elastic, Vaginal/Rectal, Tapered, Bi-Directionally Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:34.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-35740SHEATHESLH</udiDi>
    <basicUdiDi>B-35740SHEATHESLH</basicUdiDi>
    <tradeName>D-35740SHEATHESLH</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 2 Elastics, Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35740</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:37:18.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-35740(ITL)SHEATHESK5</udiDi>
    <basicUdiDi>B-35740(ITL)SHEATHESK5</basicUdiDi>
    <tradeName>D-35740(ITL)SHEATHESK5</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 2 Elastics, Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35740 (ITL)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:37:15.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-35340SHEATHESGM</udiDi>
    <basicUdiDi>B-35340SHEATHESGM</basicUdiDi>
    <tradeName>D-35340SHEATHESGM</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 2 Elastics, Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35340</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:37:06.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30740SHEATHESEQ</udiDi>
    <basicUdiDi>B-30740SHEATHESEQ</basicUdiDi>
    <tradeName>D-30740SHEATHESEQ</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 2 Elastics, Semi-Rolled on Paper-Back</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30740</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:16:54.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30740(ITL)SHEATHES9W</udiDi>
    <basicUdiDi>B-30740(ITL)SHEATHES9W</basicUdiDi>
    <tradeName>D-30740(ITL)SHEATHES9W</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 2 Elastics, Semi-Rolled on Paper-Back</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30740 (ITL)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:16:37.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30340SHEATHESAU</udiDi>
    <basicUdiDi>B-30340SHEATHESAU</basicUdiDi>
    <tradeName>D-30340SHEATHESAU</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 2 Elastics, Semi-Rolled on Paper-Back</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30340</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:08:01.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30340(ITL)SHEATHES3A</udiDi>
    <basicUdiDi>B-30340(ITL)SHEATHES3A</basicUdiDi>
    <tradeName>D-30340(ITL)SHEATHES3A</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 2 Elastics, Semi-Rolled on Paper-Back</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30340 (ITL)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:07:55.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-26840SHEATHESMC</udiDi>
    <basicUdiDi>B-26840SHEATHESMC</basicUdiDi>
    <tradeName>D-26840SHEATHESMC</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tapered, Rolled with Pull Tab, Extra-Long</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26840</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:48:23.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-26840(ITL)SHEATHESLQ</udiDi>
    <basicUdiDi>B-26840(ITL)SHEATHESLQ</basicUdiDi>
    <tradeName>D-26840(ITL)SHEATHESLQ</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tapered, Rolled with Pull Tab, Extra-Long</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26840 (ITL)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:48:22.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-25340SHEATHESFC</udiDi>
    <basicUdiDi>B-25340SHEATHESFC</basicUdiDi>
    <tradeName>D-25340SHEATHESFC</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tapered, Rolled, Extra-Long</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25340</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:48:01.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975284210029</udiDi>
    <basicUdiDi>6975284211004AF</basicUdiDi>
    <tradeName>STERILE INSTRUMENT COVER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hony Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008239</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEI16150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:07:01.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975284210043</udiDi>
    <basicUdiDi>6975284211004AF</basicUdiDi>
    <tradeName>STERILE INSTRUMENT COVER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hony Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008239</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y80-005S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:07:01.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975284210050</udiDi>
    <basicUdiDi>6975284211004AF</basicUdiDi>
    <tradeName>STERILE INSTRUMENT COVER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hony Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008239</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y80-007S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:07:01.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975284210067</udiDi>
    <basicUdiDi>6975284211004AF</basicUdiDi>
    <tradeName>STERILE INSTRUMENT COVER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hony Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008239</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y80-057S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:07:01.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975284210074</udiDi>
    <basicUdiDi>6975284211004AF</basicUdiDi>
    <tradeName>STERILE INSTRUMENT COVER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hony Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008239</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y80-200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:07:01.337Z</lastUpdated>
  </row>
</eudamedExport>