<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06970167440442</udiDi>
    <basicUdiDi>6970167440000000000000034</basicUdiDi>
    <tradeName>NeuViz Epoch+</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>Z11030607</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:31:03.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167440435</udiDi>
    <basicUdiDi>6970167440000000000000034</basicUdiDi>
    <tradeName>NeuViz Glory+</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>Z11030607</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:31:02.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167440428</udiDi>
    <basicUdiDi>6970167440000000000000034</basicUdiDi>
    <tradeName>NeuViz ACE 32e</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>2026-06-29T20:31:01.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167440411</udiDi>
    <basicUdiDi>6970167440000000000000034</basicUdiDi>
    <tradeName>NeuViz ACE 128</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>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:30:55.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167440404</udiDi>
    <basicUdiDi>6970167440000000000000034</basicUdiDi>
    <tradeName>NeuViz ACE 64e</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>Z11030605</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:30:54.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167440398</udiDi>
    <basicUdiDi>6970167440000000000000034</basicUdiDi>
    <tradeName>NeuViz ACE 64i</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>Z11030605</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:30:53.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167440381</udiDi>
    <basicUdiDi>6970167440000000000000034</basicUdiDi>
    <tradeName>NeuViz ACE UP</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>Z11030605</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:30:51.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167440350</udiDi>
    <basicUdiDi>6970167440000000000000034</basicUdiDi>
    <tradeName>NeuViz Epoch</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>Z11030607</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:30:45.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167440336</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>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:30:44.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167440329</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>2026-06-29T20:30:43.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167440312</udiDi>
    <basicUdiDi>B-06970167440312</basicUdiDi>
    <tradeName>NeuViz 16 Classic</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>MDD</legislation>
    <emdnCode>Z11030603</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:30:42.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167440305</udiDi>
    <basicUdiDi>697016744000000000000043C</basicUdiDi>
    <tradeName>NeuMR Rena C</tradeName>
    <deviceName>Medical Magnetic Resonance Imaging 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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:30:35.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167440114</udiDi>
    <basicUdiDi>6970167440000000000000034</basicUdiDi>
    <tradeName>NeuViz Glory</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>Z11030607</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:30:33.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167440084</udiDi>
    <basicUdiDi>B-06970167440084</basicUdiDi>
    <tradeName>NeuViz 16 Essence</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>MDD</legislation>
    <emdnCode>Z11030603</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:30:32.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167440077</udiDi>
    <basicUdiDi>B-06970167440077</basicUdiDi>
    <tradeName>NeuViz Prime</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>MDD</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:30:31.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970167440022</udiDi>
    <basicUdiDi>B-06970167440022</basicUdiDi>
    <tradeName>NeuViz 64 In</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>MDD</legislation>
    <emdnCode>Z11030605</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:30:25.436Z</lastUpdated>
  </row>
</eudamedExport>