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<eudamedExport entity="devices">
  <row>
    <udiDi>05056190501303</udiDi>
    <basicUdiDi>5056190500573VE</basicUdiDi>
    <tradeName>AlignRT 8.2.x</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vision RT Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000010499</manufacturerSrn>
    <authorisedRepresentativeName>Oticon A/S</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000006135</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AlignRT InBore 8.2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:15.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056190501334</udiDi>
    <basicUdiDi>5056190500573VE</basicUdiDi>
    <tradeName>AlignRT InBore Accuray Control Box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vision RT Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000010499</manufacturerSrn>
    <authorisedRepresentativeName>Oticon A/S</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000006135</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V001127</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:15.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056190501372</udiDi>
    <basicUdiDi>5056190500573VE</basicUdiDi>
    <tradeName>AlignRT InBore Accuray</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vision RT Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000010499</manufacturerSrn>
    <authorisedRepresentativeName>Oticon A/S</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000006135</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11019099</emdnCode>
    <emdnDescription>VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05056190501372</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:35:14.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950291110466</udiDi>
    <basicUdiDi>69502911DR3YB</basicUdiDi>
    <tradeName>06950291110466</tradeName>
    <deviceName>Mammography</deviceName>
    <manufacturerName>Sino Medical-Device Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007089</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Navigator DR Care</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:19:27.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950291110169</udiDi>
    <basicUdiDi>69502911MTQ</basicUdiDi>
    <tradeName>06950291110169</tradeName>
    <deviceName>Mammography</deviceName>
    <manufacturerName>Sino Medical-Device Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007089</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Navigator Star</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:19:19.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021134</udiDi>
    <basicUdiDi>69454290CG001HH</basicUdiDi>
    <tradeName>Catheter-positioning guiding system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040104</emdnCode>
    <emdnDescription>MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U8</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:11:46.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429002829</udiDi>
    <basicUdiDi>69454290DU001LW</basicUdiDi>
    <tradeName>Diagnostic Ultrasound System</tradeName>
    <deviceName>Diagnostic Ultrasound System</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>EP30PR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:11:15.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121414524</udiDi>
    <basicUdiDi>69451214SonoAirZL</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName>Digital Color Doppler Ultrasound System</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040104</emdnCode>
    <emdnDescription>MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SonoAir 60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:42.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121413237</udiDi>
    <basicUdiDi>69451214XBitYH</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName>Diqital Color Doppler Ultrasound Svstem</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040104</emdnCode>
    <emdnDescription>MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XBit 70</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:41.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121415637</udiDi>
    <basicUdiDi>69451214SonoPortVG</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName>Digital Color Doppler Ultrasound System</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040104</emdnCode>
    <emdnDescription>MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SonoPort 8</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:41.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121414814</udiDi>
    <basicUdiDi>69451214SonoMax37</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName>Digital Color Doppler Ultrasound System</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040104</emdnCode>
    <emdnDescription>MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SonoMax 9</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:40.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121413176</udiDi>
    <basicUdiDi>69451214P6CS</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName>Digital Color Doppler Palm Ultrasound System</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SonoEye P6</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:23.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121413091</udiDi>
    <basicUdiDi>69451214P5CQ</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName>Digital Color Doppler Palm Ultrasound System</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SonoEye P5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:22.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121413084</udiDi>
    <basicUdiDi>69451214P3CL</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName>Digital Color Doppler Palm Ultrasound System</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SonoEye P3</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:21.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121413077</udiDi>
    <basicUdiDi>69451214P2CJ</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName>Digital Color Doppler Palm Ultrasound System</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SonoEye P2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:21.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121413060</udiDi>
    <basicUdiDi>69451214P1CG</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName>Digital Color Doppler Palm Ultrasound System</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SonoEye P1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:17.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121411172</udiDi>
    <basicUdiDi>69451214SonoBookRK</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName>Digital Color Doppler Ultrasound System</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SonoBook 9</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:16.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121403221</udiDi>
    <basicUdiDi>69451214QBitWY</basicUdiDi>
    <tradeName>06945121403221</tradeName>
    <deviceName>Digital Color Doppler Ultrasound System</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040104</emdnCode>
    <emdnDescription>MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QBit 5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:15.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945121400107</udiDi>
    <basicUdiDi>69451214CBitTW</basicUdiDi>
    <tradeName>CHISON</tradeName>
    <deviceName>Digital Color Doppler Ultrasound System</deviceName>
    <manufacturerName>CHISON Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021605</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1104018099</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D3C60L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:14.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945040106593</udiDi>
    <basicUdiDi>69450401CMS1700DT</basicUdiDi>
    <tradeName>Color Doppler Ultrasound Diagnostic System</tradeName>
    <deviceName>Color Doppler Ultrasound Diagnostic System</deviceName>
    <manufacturerName>Contec Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007715</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040105</emdnCode>
    <emdnDescription>OBSTETRIC/GYNAECOLOGICAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMS1700B</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:03:49.045Z</lastUpdated>
  </row>
</eudamedExport>