<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06971576834082</udiDi>
    <basicUdiDi>697157683408NQ</basicUdiDi>
    <tradeName>06971576834082</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai United Imaging Healthcare Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008501</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000843</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:06:29.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576831494</udiDi>
    <basicUdiDi>697157683149NP</basicUdiDi>
    <tradeName>06971576831494</tradeName>
    <deviceName>Computed Tomography X-ray System</deviceName>
    <manufacturerName>Shanghai United Imaging Healthcare Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008501</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030607</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000944</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:29.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576831432</udiDi>
    <basicUdiDi>697157683143NB</basicUdiDi>
    <tradeName>06971576831432</tradeName>
    <deviceName>Computed Tomography X-ray System</deviceName>
    <manufacturerName>Shanghai United Imaging Healthcare Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008501</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030603</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88001125</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:28.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576831425</udiDi>
    <basicUdiDi>697157683142N9</basicUdiDi>
    <tradeName>06971576831425</tradeName>
    <deviceName>Computed Tomography X-ray System</deviceName>
    <manufacturerName>Shanghai United Imaging Healthcare Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008501</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030603</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88001123</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:28.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576831111</udiDi>
    <basicUdiDi>697157683111MW</basicUdiDi>
    <tradeName>06971576831111</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai United Imaging Healthcare Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008501</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000647</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:27.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>19356870000038</udiDi>
    <basicUdiDi>193568700CT:VQE3</basicUdiDi>
    <tradeName>CT:VQ</tradeName>
    <deviceName>CT:VQ</deviceName>
    <manufacturerName>4D Medical Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000050621</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030699</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT:VQ</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:09:30.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938964319088</udiDi>
    <basicUdiDi>693896431900PA</basicUdiDi>
    <tradeName>06938964319088</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Wandong Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014174</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030605</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:55:15.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938964319156</udiDi>
    <basicUdiDi>693896431900PA</basicUdiDi>
    <tradeName>06938964319156</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Wandong Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014174</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030605</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:55:15.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938964319187</udiDi>
    <basicUdiDi>693896431900PA</basicUdiDi>
    <tradeName>06938964319187</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Wandong Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014174</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030605</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:55:15.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938964319248</udiDi>
    <basicUdiDi>693896431900PA</basicUdiDi>
    <tradeName>06938964319248</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Wandong Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014174</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030605</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:55:15.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938964319262</udiDi>
    <basicUdiDi>693896431900PA</basicUdiDi>
    <tradeName>06938964319262</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Wandong Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014174</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030605</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:55:15.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938964319279</udiDi>
    <basicUdiDi>693896431900PA</basicUdiDi>
    <tradeName>06938964319279</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Wandong Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014174</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030605</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:55:15.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260483290244</udiDi>
    <basicUdiDi>0426048329VEO35</basicUdiDi>
    <tradeName>Veolity</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MeVis Medical Solutions AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005418</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030682</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Veo-2200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:01:28.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260483290268</udiDi>
    <basicUdiDi>0426048329MVLSXH</basicUdiDi>
    <tradeName>04260483290268</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MeVis Medical Solutions AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005418</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030682</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MVLS 1.3 ROW / MVLS-View 1.3-S ROW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:01:28.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260483290282</udiDi>
    <basicUdiDi>0426048329MVLSXH</basicUdiDi>
    <tradeName>MeVis Liver Suite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MeVis Medical Solutions AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005418</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030682</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MVLS-1.3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:01:28.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970614965245</udiDi>
    <basicUdiDi>697061496030002QW</basicUdiDi>
    <tradeName>X-Ray Equipment for Computed Tomography</tradeName>
    <deviceName>X-ray equipment for computed tomography</deviceName>
    <manufacturerName>Shinva Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009856</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011194</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030603</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>XHCT-16</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:22:41.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167443351</udiDi>
    <basicUdiDi>6970167440000000000000034</basicUdiDi>
    <tradeName>NeuViz Prime Max+</tradeName>
    <deviceName>MULTI-SLICE CT SCANNER SYSTEM</deviceName>
    <manufacturerName>Neusoft Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011819</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:31:51.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167442200</udiDi>
    <basicUdiDi>6970167440000000000000034</basicUdiDi>
    <tradeName>NeuViz ACE SP</tradeName>
    <deviceName>MULTI-SLICE CT SCANNER SYSTEM</deviceName>
    <manufacturerName>Neusoft Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011819</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030603</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:31:39.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167442194</udiDi>
    <basicUdiDi>6970167440000000000000034</basicUdiDi>
    <tradeName>NeuViz ACE</tradeName>
    <deviceName>MULTI-SLICE CT SCANNER SYSTEM</deviceName>
    <manufacturerName>Neusoft Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011819</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030603</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:31:33.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167441623</udiDi>
    <basicUdiDi>6970167440000000000000034</basicUdiDi>
    <tradeName>NeuViz ACE 32</tradeName>
    <deviceName>MULTI-SLICE CT SCANNER SYSTEM</deviceName>
    <manufacturerName>Neusoft Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011819</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030603</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:31:21.821Z</lastUpdated>
  </row>
</eudamedExport>