<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800289979224</udiDi>
    <basicUdiDi>880972578USP001WH</basicUdiDi>
    <tradeName>EA2-11ARn</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAMSUNG MEDISON CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000011620</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1104020201</emdnCode>
    <emdnDescription>ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:53:35.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800289970351</udiDi>
    <basicUdiDi>880972578USS001X6</basicUdiDi>
    <tradeName>cV8</tradeName>
    <deviceName>Ultrasound Scanner</deviceName>
    <manufacturerName>SAMSUNG MEDISON CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000011620</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:53:34.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806095799636</udiDi>
    <basicUdiDi>8806090DGRGF001W2</basicUdiDi>
    <tradeName>GF85-3P</tradeName>
    <deviceName>Digital Diagnostic X-ray System</deviceName>
    <manufacturerName>Samsung Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000020682</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF85-3P</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:37:51.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806094936872</udiDi>
    <basicUdiDi>8806094936896BY</basicUdiDi>
    <tradeName>Sleep Apnea Feature</tradeName>
    <deviceName>Sleep Apnea Feature</deviceName>
    <manufacturerName>Samsung Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023537</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040182</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v1.X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:37:49.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806090792021</udiDi>
    <basicUdiDi>88060940602706J</basicUdiDi>
    <tradeName>ECG App</tradeName>
    <deviceName>ECG App</deviceName>
    <manufacturerName>Samsung Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023537</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040182</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v1.1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:37:44.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806090792014</udiDi>
    <basicUdiDi>88060940597178T</basicUdiDi>
    <tradeName>Blood Pressure App</tradeName>
    <deviceName>Blood Pressure App</deviceName>
    <manufacturerName>Samsung Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000023537</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040182</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v1.1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:37:43.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806088773797</udiDi>
    <basicUdiDi>8806090DGRGR001YN</basicUdiDi>
    <tradeName>GR40CW</tradeName>
    <deviceName>Retrofit kit for digital radiography</deviceName>
    <manufacturerName>Samsung Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000020682</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR40CW</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:37:40.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806088582412</udiDi>
    <basicUdiDi>8806090DGRGM001XK</basicUdiDi>
    <tradeName>GM85</tradeName>
    <deviceName>Digital Diagnostic Mobile X-ray System</deviceName>
    <manufacturerName>Samsung Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000020682</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GM85</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:37:39.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806088565231</udiDi>
    <basicUdiDi>8806090DGRGC001VD</basicUdiDi>
    <tradeName>GC85A</tradeName>
    <deviceName>Digital Diagnostic X-ray System</deviceName>
    <manufacturerName>Samsung Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000020682</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GC85A</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:37:38.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>08801643467098</udiDi>
    <basicUdiDi>8806090DGRSW0015Y</basicUdiDi>
    <tradeName>Auto Lung Nodule Detection</tradeName>
    <deviceName>Application Software for Digital Diagnostic X-ray System</deviceName>
    <manufacturerName>Samsung Electronics Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000020682</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031192</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Auto Lung Nodule Detection</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:37:27.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809521022179</udiDi>
    <basicUdiDi>880972578USP001WH</basicUdiDi>
    <tradeName>CV1-8AD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAMSUNG MEDISON CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000011620</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1104020201</emdnCode>
    <emdnDescription>ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:22.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809521023718</udiDi>
    <basicUdiDi>880972578USP001WH</basicUdiDi>
    <tradeName>CA1-7S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAMSUNG MEDISON CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000011620</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1104020201</emdnCode>
    <emdnDescription>ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:21.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809521028836</udiDi>
    <basicUdiDi>880972578USP001WH</basicUdiDi>
    <tradeName>LA4-18A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAMSUNG MEDISON CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000011620</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1104020201</emdnCode>
    <emdnDescription>ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:04:21.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800357308208</udiDi>
    <basicUdiDi>880972578USS001X6</basicUdiDi>
    <tradeName>V8 ONE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAMSUNG MEDISON CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000011620</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:43:18.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809944870029</udiDi>
    <basicUdiDi>880972578USS001X6</basicUdiDi>
    <tradeName>RS85</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAMSUNG MEDISON CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000011620</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:10:10.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809944870036</udiDi>
    <basicUdiDi>880972578USS001X6</basicUdiDi>
    <tradeName>RS85</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAMSUNG MEDISON CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000011620</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:10:10.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809944870081</udiDi>
    <basicUdiDi>880972578USS001X6</basicUdiDi>
    <tradeName>RS85</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAMSUNG MEDISON CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000011620</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:10:10.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809944870128</udiDi>
    <basicUdiDi>880972578USS001X6</basicUdiDi>
    <tradeName>RS85</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAMSUNG MEDISON CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000011620</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:10:10.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809944870241</udiDi>
    <basicUdiDi>880972578USS001X6</basicUdiDi>
    <tradeName>RS85</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAMSUNG MEDISON CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000011620</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:10:10.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809944870258</udiDi>
    <basicUdiDi>880972578USS001X6</basicUdiDi>
    <tradeName>RS85</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAMSUNG MEDISON CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000011620</manufacturerSrn>
    <authorisedRepresentativeName>Samsung Electronics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007005</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:10:10.597Z</lastUpdated>
  </row>
</eudamedExport>