<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>06927716902630</udiDi>
    <basicUdiDi>69277169002GLT003F3</basicUdiDi>
    <tradeName>Sterile Ultrasound Probe Cover Kit</tradeName>
    <deviceName>Sterile Ultrasound Probe Cover Kit</deviceName>
    <manufacturerName>Shenzhen Rising Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036422</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELS-3D-610-g</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:28:59.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>15425029890197</udiDi>
    <basicUdiDi>542502989USUN</basicUdiDi>
    <tradeName>NAQI UltraSon Gel  500 ml  shipper</tradeName>
    <deviceName>Ultrason gel</deviceName>
    <manufacturerName>Naqi NV</manufacturerName>
    <manufacturerSrn>BE-MF-000001241</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>us500-bulk</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:02:52.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>10841436104316</udiDi>
    <basicUdiDi>0841436101TD303ALP</basicUdiDi>
    <tradeName>Endocavity Balloon</tradeName>
    <deviceName>Endocavity Standoffs</deviceName>
    <manufacturerName>CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions</manufacturerName>
    <manufacturerSrn>US-MF-000008229</manufacturerSrn>
    <authorisedRepresentativeName>MPS Medical Product Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005009</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610-898</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:15:49.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GPSSRLFP500CW</udiDi>
    <basicUdiDi>B-GPSSRLFP500CW</basicUdiDi>
    <tradeName>GPS</tradeName>
    <deviceName>Non-Sterile Natural Rubber Latex Protective Transducer Covers</deviceName>
    <manufacturerName>Karex Industries Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001247</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KX07</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:42:39.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>29556564094962</udiDi>
    <basicUdiDi>B-29556564094962</basicUdiDi>
    <tradeName>Curamor</tradeName>
    <deviceName>Non-Sterile Natural Rubber Latex Protective Transducer Covers</deviceName>
    <manufacturerName>Karex Industries Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001247</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KX07</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:24:04.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>29556564094849</udiDi>
    <basicUdiDi>B-29556564094849</basicUdiDi>
    <tradeName>Protective Transducer Cover</tradeName>
    <deviceName>Non-Sterile Natural Rubber Latex Protective Transducer Covers</deviceName>
    <manufacturerName>Karex Industries Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001247</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040185</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KX06</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:23:58.170Z</lastUpdated>
  </row>
</eudamedExport>