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<eudamedExport entity="devices">
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    <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>
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  <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>
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  <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>
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    <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>
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  <row>
    <udiDi>08800070400043</udiDi>
    <basicUdiDi>88000704HAAP-27U</basicUdiDi>
    <tradeName>08800070400043</tradeName>
    <deviceName>Digital Flat Panel X-ray Detector</deviceName>
    <manufacturerName>H&amp;abyz</manufacturerName>
    <manufacturerSrn>KR-MF-000020684</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1717MCW, A1417MCW, F1417MCW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:27:31.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800070400012</udiDi>
    <basicUdiDi>88000704HAAP-17S</basicUdiDi>
    <tradeName>08800070400012</tradeName>
    <deviceName>Digital Flat Panel X-ray Detector</deviceName>
    <manufacturerName>H&amp;abyz</manufacturerName>
    <manufacturerSrn>KR-MF-000020684</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</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>HAD1717MC, HAD1717MG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:27:31.511Z</lastUpdated>
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  <row>
    <udiDi>08800070400005</udiDi>
    <basicUdiDi>88000704ADDTE</basicUdiDi>
    <tradeName>08800070400005</tradeName>
    <deviceName>Digital flat panel X-ray detector</deviceName>
    <manufacturerName>H&amp;abyz</manufacturerName>
    <manufacturerSrn>KR-MF-000020684</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</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>ADD(HAD1417MCW)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:27:30.243Z</lastUpdated>
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  <row>
    <udiDi>08800018405406</udiDi>
    <basicUdiDi>88000184DGXXXXXXXXRV</basicUdiDi>
    <tradeName>EVS 4343A</tradeName>
    <deviceName>Flat Panel Digital X-ray Detector</deviceName>
    <manufacturerName>DRTECH Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000012441</manufacturerSrn>
    <authorisedRepresentativeName>DRTECH Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011974</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVS 4343A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:07.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800018401903</udiDi>
    <basicUdiDi>88000184DMXXXXXXXXW7</basicUdiDi>
    <tradeName>RSM 2430C</tradeName>
    <deviceName>Flat-Panel Digital X-ray Detector</deviceName>
    <manufacturerName>DRTECH Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000012441</manufacturerSrn>
    <authorisedRepresentativeName>DRTECH Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011974</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSM 2430C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:06.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011150129</udiDi>
    <basicUdiDi>88000111DMR50002G</basicUdiDi>
    <tradeName>RAYMO</tradeName>
    <deviceName>Mobile X-ray System</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>RAYMO</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:16:11.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011150105</udiDi>
    <basicUdiDi>88000111DMP5000ZP</basicUdiDi>
    <tradeName>PROMO</tradeName>
    <deviceName>Mobile X-ray System</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>PROMO</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:16:10.227Z</lastUpdated>
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  <row>
    <udiDi>08800011150006</udiDi>
    <basicUdiDi>88000111DM5000VU</basicUdiDi>
    <tradeName>TOPAZ-32D</tradeName>
    <deviceName>Mobile X-ray System</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>TOPAZ-32D</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:16:05.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011140038</udiDi>
    <basicUdiDi>88000111DSGSD4000PB</basicUdiDi>
    <tradeName>GXR-32SD</tradeName>
    <deviceName>Digital diagnostic X-ray System</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>GXR-32SD</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:16:04.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011140007</udiDi>
    <basicUdiDi>88000111DSDIA4000GM</basicUdiDi>
    <tradeName>DIAMOND-5A</tradeName>
    <deviceName>Digital diagnostic X-ray System</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>DIAMOND-5A</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:16:03.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057737121715</udiDi>
    <basicUdiDi>805773712FT2529R</basicUdiDi>
    <tradeName>Armonicus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Villa Sistemi Medicali S.p.A.</manufacturerName>
    <manufacturerSrn>IT-PR-000027254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9785063100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:51:40.854Z</lastUpdated>
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    <udiDi>08055186671201</udiDi>
    <basicUdiDi>805518667HIRISTSIEW</basicUdiDi>
    <tradeName>DRF 4343-LT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>A.T.S. Applicazione Tecnologie Speciali s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000010734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031192</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SI 11 001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:25:40.224Z</lastUpdated>
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    <udiDi>08055186671195</udiDi>
    <basicUdiDi>805518667PRIMOSS4</basicUdiDi>
    <tradeName>08055186671195</tradeName>
    <deviceName></deviceName>
    <manufacturerName>A.T.S. Applicazione Tecnologie Speciali s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000010734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031192</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SI 92 002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:25:24.950Z</lastUpdated>
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  <row>
    <udiDi>08053470390005</udiDi>
    <basicUdiDi>805347039TIRESYAWB</basicUdiDi>
    <tradeName>TESEO</tradeName>
    <deviceName>TIRESYA</deviceName>
    <manufacturerName>Digitec S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007792</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031192</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRX_01_001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:42:49.501Z</lastUpdated>
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    <udiDi>07649996713056</udiDi>
    <basicUdiDi>7649996713Geneve-40M-FaD4</basicUdiDi>
    <tradeName>Genève 40 M</tradeName>
    <deviceName>Multifunctional Systems for Direct Digital Radiology</deviceName>
    <manufacturerName>General Medical Italia LTD Swiss Branch</manufacturerName>
    <manufacturerSrn>CH-MF-000030023</manufacturerSrn>
    <authorisedRepresentativeName>ITALIAN RADIOLOGY INDUSTRY SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000037736</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>GMIG40S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:56:03.854Z</lastUpdated>
  </row>
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    <udiDi>07649996713049</udiDi>
    <basicUdiDi>7649996713Lucerna-RF-FaVB</basicUdiDi>
    <tradeName>Lucerna RF-TILT</tradeName>
    <deviceName>Multifunctional Systems for Direct Digital Radiology</deviceName>
    <manufacturerName>General Medical Italia LTD Swiss Branch</manufacturerName>
    <manufacturerSrn>CH-MF-000030023</manufacturerSrn>
    <authorisedRepresentativeName>ITALIAN RADIOLOGY INDUSTRY SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000037736</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>GMILOA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:56:03.057Z</lastUpdated>
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