<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-5-363KITSHEATHESN4</udiDi>
    <basicUdiDi>B-5-363KITSHEATHESN4</basicUdiDi>
    <tradeName>D-5-363KITSHEATHESN4</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 20ml Sterile Gel &amp; 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-363 KIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:14:24.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5-3635KITSHEATHESMF</udiDi>
    <basicUdiDi>B-5-3635KITSHEATHESMF</basicUdiDi>
    <tradeName>D-5-3635KITSHEATHESMF</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 20ml Sterile Gel &amp; 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-3635 KIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:14:23.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5-3635KIT(ITL)TL</udiDi>
    <basicUdiDi>B-5-3635KIT(ITL)TL</basicUdiDi>
    <tradeName>D-5-3635KIT(ITL)TL</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 20ml Sterile Gel &amp; 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-3635 KIT (ITL)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:13:56.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5-304KITSHEATHESFK</udiDi>
    <basicUdiDi>B-5-304KITSHEATHESFK</basicUdiDi>
    <tradeName>D-5-304KITSHEATHESFK</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 20ml Sterile Gel &amp; 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-304 KIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:13:52.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5-3035KITSHEATHESDD</udiDi>
    <basicUdiDi>B-5-3035KITSHEATHESDD</basicUdiDi>
    <tradeName>D-5-3035KITSHEATHESDD</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 20ml Sterile Gel &amp; 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-3035 KIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:13:52.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5-30340KITSHEATHES64</udiDi>
    <basicUdiDi>B-5-30340KITSHEATHES64</basicUdiDi>
    <tradeName>D-5-30340KITSHEATHES64</tradeName>
    <deviceName>Sterile, Specialty Ultrasound Probe Cover with 20ml Sterile Gel &amp; 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>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-30340 KIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:13:51.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5-30340KIT(ITL)9Z</udiDi>
    <basicUdiDi>B-5-30340KIT(ITL)9Z</basicUdiDi>
    <tradeName>D-5-30340KIT(ITL)9Z</tradeName>
    <deviceName>Sterile, Specialty Ultrasound Probe Cover with 20ml Sterile Gel &amp; 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>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-30340 KIT (ITL)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:13:50.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5-25340KITSHEATHESBS</udiDi>
    <basicUdiDi>B-5-25340KITSHEATHESBS</basicUdiDi>
    <tradeName>D-5-25340KITSHEATHESBS</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 20ml Sterile Gel &amp; 1 Elastic, Vaginal/Rectal, Tapered, 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>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-25340 KIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:13:46.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5-246KITSHEATHESMN</udiDi>
    <basicUdiDi>B-5-246KITSHEATHESMN</basicUdiDi>
    <tradeName>D-5-246KITSHEATHESMN</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 20ml Sterile Gel &amp; 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-246 KIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:13:45.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5-245KITSHEATHESLH</udiDi>
    <basicUdiDi>B-5-245KITSHEATHESLH</basicUdiDi>
    <tradeName>D-5-245KITSHEATHESLH</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 20ml Sterile Gel &amp; 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-245 KIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:13:44.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5-245KIT(ITL)SHEATHESY5</udiDi>
    <basicUdiDi>B-5-245KIT(ITL)SHEATHESY5</basicUdiDi>
    <tradeName>D-5-245KIT(ITL)SHEATHESY5</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 20ml Sterile Gel &amp; 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-245 KIT (ITL)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:13:43.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5-244KITSHEATHESKC</udiDi>
    <basicUdiDi>B-5-244KITSHEATHESKC</basicUdiDi>
    <tradeName>D-5-244KITSHEATHESKC</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 20ml Sterile Gel &amp; 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-244 KIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:13:40.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5-2445TKITSHEATHESMH</udiDi>
    <basicUdiDi>B-5-2445TKITSHEATHESMH</basicUdiDi>
    <tradeName>D-5-2445TKITSHEATHESMH</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 20ml Sterile Gel &amp; 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-2445T KIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:13:39.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5-2435KITSHEATHESHA</udiDi>
    <basicUdiDi>B-5-2435KITSHEATHESHA</basicUdiDi>
    <tradeName>D-5-2435KITSHEATHESHA</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 20ml Sterile Gel &amp; 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-2435 KIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:13:38.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5-241CTKITSHEATHES28</udiDi>
    <basicUdiDi>B-5-241CTKITSHEATHES28</basicUdiDi>
    <tradeName>D-5-241CTKITSHEATHES28</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 20ml Sterile Gel &amp; 2 Elastics, Intraoperative, Custom Tip, Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-241CT KIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:13:37.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5-10040KITSHEATHESWN</udiDi>
    <basicUdiDi>B-5-10040KITSHEATHESWN</basicUdiDi>
    <tradeName>D-5-10040KITSHEATHESWN</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 20ml Sterile Gel &amp; 1 Elastic, Vaginal/Rectal, Seamless, Straight, 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>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5-10040 KIT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:13:33.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560141947917</udiDi>
    <basicUdiDi>B-04560141947917</basicUdiDi>
    <tradeName>04560141947917</tradeName>
    <deviceName>ACK2</deviceName>
    <manufacturerName>Konica Minolta, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000008214</manufacturerSrn>
    <authorisedRepresentativeName>Konica Minolta Business Solutions Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002026</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACK2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:34:03.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560141947900</udiDi>
    <basicUdiDi>B-04560141947900</basicUdiDi>
    <tradeName>04560141947900</tradeName>
    <deviceName>ACK1</deviceName>
    <manufacturerName>Konica Minolta, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000008214</manufacturerSrn>
    <authorisedRepresentativeName>Konica Minolta Business Solutions Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002026</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACK1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:34:03.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560141947894</udiDi>
    <basicUdiDi>B-04560141947894</basicUdiDi>
    <tradeName>04560141947894</tradeName>
    <deviceName>ACK0</deviceName>
    <manufacturerName>Konica Minolta, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000008214</manufacturerSrn>
    <authorisedRepresentativeName>Konica Minolta Business Solutions Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002026</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACK0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:34:01.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560141947436</udiDi>
    <basicUdiDi>B-04560141947436</basicUdiDi>
    <tradeName>04560141947436</tradeName>
    <deviceName>AC7H</deviceName>
    <manufacturerName>Konica Minolta, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000008214</manufacturerSrn>
    <authorisedRepresentativeName>Konica Minolta Business Solutions Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002026</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC7H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:33:57.798Z</lastUpdated>
  </row>
</eudamedExport>