<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>20848340000335</udiDi>
    <basicUdiDi>B-20848340000335</basicUdiDi>
    <tradeName>20848340000335</tradeName>
    <deviceName>Low Dense Polyethylene Snap Kover 40" X 30"</deviceName>
    <manufacturerName>Advance Medical Designs, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009790</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>01-4030-6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:02:14.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>20848340000281</udiDi>
    <basicUdiDi>B-20848340000281</basicUdiDi>
    <tradeName>20848340000281</tradeName>
    <deviceName>Low Dense Polyethylene Snap Kover 36" X 48"</deviceName>
    <manufacturerName>Advance Medical Designs, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009790</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>01-3648-6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:02:10.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555012422503</udiDi>
    <basicUdiDi>B-19555012422503</basicUdiDi>
    <tradeName>Henry Schein Ultrasound Probe Covers Without Lubricant</tradeName>
    <deviceName>NON-STERILE NATURAL RUBBER LATEX ULTRASONIC PROBE COVERS</deviceName>
    <manufacturerName>PLEASURE LATEX PRODUCTS SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000016199</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>572-2781</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:14:39.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555012422251</udiDi>
    <basicUdiDi>B-19555012422251</basicUdiDi>
    <tradeName>NEXODIS LATEX ULTRASOUND PROBE COVERS POWDERED (NAKED TESTED)</tradeName>
    <deviceName>NON-STERILE NATURAL RUBBER LATEX ULTRASONIC PROBE COVERS</deviceName>
    <manufacturerName>PLEASURE LATEX PRODUCTS SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000016199</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Pcv1-b(53WN08-ZN)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:14:26.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555012422275</udiDi>
    <basicUdiDi>B-19555012422275</basicUdiDi>
    <tradeName>NEXODIS LATEX ULTRASOUND PROBE COVERS POWDERED (NON-LUBRICATED)</tradeName>
    <deviceName>NON-STERILE NATURAL RUBBER LATEX ULTRASONIC PROBE COVERS</deviceName>
    <manufacturerName>PLEASURE LATEX PRODUCTS SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000016199</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCv1-b(53WN08-ZN)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:14:24.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555012422268</udiDi>
    <basicUdiDi>B-19555012422268</basicUdiDi>
    <tradeName>NEXODIS LATEX ULTRASOUND PROBE COVERS (LUBRICATED)</tradeName>
    <deviceName>NEXODIS LATEX ULTRASOUND PROBE COVER (LUBRICATED)</deviceName>
    <manufacturerName>PLEASURE LATEX PRODUCTS SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000016199</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCv2-b(53WN08-PN)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:14:24.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555012421872</udiDi>
    <basicUdiDi>B-19555012421872</basicUdiDi>
    <tradeName>Protectline Ultrasound Probe Cover Lubricated</tradeName>
    <deviceName>NON-STERILE NATURAL RUBBER LATEX ULTRASONIC PROBE COVERS</deviceName>
    <manufacturerName>PLEASURE LATEX PRODUCTS SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000016199</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53WN08-PN</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:13:59.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555012421827</udiDi>
    <basicUdiDi>B-19555012421827</basicUdiDi>
    <tradeName>Protectline Ultrasound Probe Cover Non-Lubricated</tradeName>
    <deviceName>NON-STERILE NATURAL RUBBER LATEX ULTRASONIC PROBE COVERS</deviceName>
    <manufacturerName>PLEASURE LATEX PRODUCTS SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000016199</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53WN08-ZN</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:13:55.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555012421810</udiDi>
    <basicUdiDi>B-19555012421810</basicUdiDi>
    <tradeName>Protectline Ultrasound Probe Cover Naked Tested</tradeName>
    <deviceName>NON-STERILE NATURAL RUBBER LATEX ULTRASONIC PROBE COVERS</deviceName>
    <manufacturerName>PLEASURE LATEX PRODUCTS SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000016199</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53WN08</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:13:54.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555012421315</udiDi>
    <basicUdiDi>B-19555012421315</basicUdiDi>
    <tradeName>NEXODIS LATEX ULTRASOUND PROBE COVERS (LUBRICATED)</tradeName>
    <deviceName>NATURAL RUBBER LATEX PROBE COVER</deviceName>
    <manufacturerName>PLEASURE LATEX PRODUCTS SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000016199</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53WN08-PN</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:12:33.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>19555012421308</udiDi>
    <basicUdiDi>B-19555012421308</basicUdiDi>
    <tradeName>NEXODIS LATEX ULTRASOUND PROBE COVERS POWDERED (NON-LUBRICATED)</tradeName>
    <deviceName>NATURAL RUBBER LATEX PROBE COVER</deviceName>
    <manufacturerName>PLEASURE LATEX PRODUCTS SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000016199</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCv1-b(53WN08-ZN)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:12:31.068Z</lastUpdated>
  </row>
</eudamedExport>