<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06971576830442</udiDi>
    <basicUdiDi>697157683044N8</basicUdiDi>
    <tradeName>06971576830442</tradeName>
    <deviceName>Magnetic Resonance Imaging 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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050105</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88001215</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:21.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576830435</udiDi>
    <basicUdiDi>697157683043N6</basicUdiDi>
    <tradeName>06971576830435</tradeName>
    <deviceName>Magnetic Resonance Imaging 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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050106</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 4T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000220</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:20.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576830114</udiDi>
    <basicUdiDi>697157683011MR</basicUdiDi>
    <tradeName>06971576830114</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>Z11050105</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000196</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:16.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576830107</udiDi>
    <basicUdiDi>697157683010MP</basicUdiDi>
    <tradeName>06971576830107</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>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000654</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:16.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576830091</udiDi>
    <basicUdiDi>697157683009N6</basicUdiDi>
    <tradeName>06971576830091</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>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000653</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:15.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576830077</udiDi>
    <basicUdiDi>697157683007N2</basicUdiDi>
    <tradeName>06971576830077</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>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000099</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:14.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576830060</udiDi>
    <basicUdiDi>697157683006MY</basicUdiDi>
    <tradeName>06971576830060</tradeName>
    <deviceName>Magnetic Resonance Imaging 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 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>uMR 580</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:10.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904126061080</udiDi>
    <basicUdiDi>5904126-PJ-MR/B2</basicUdiDi>
    <tradeName>Parawan jezdny PJ-MR</tradeName>
    <deviceName>Parawany jezdne PJ-MR</deviceName>
    <manufacturerName>Zakład Techniki Medycznej "Tech-Med" Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000009262</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11059099</emdnCode>
    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PJ2-02-M-MR</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:41:43.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904126017971</udiDi>
    <basicUdiDi>5904126-C-MR/8C</basicUdiDi>
    <tradeName>Wózek oddziałowy wielofunkcyjny C-MR</tradeName>
    <deviceName>Wózki oddziałowe wielofunkcyjne C-MR</deviceName>
    <manufacturerName>Zakład Techniki Medycznej "Tech-Med" Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000009262</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11059099</emdnCode>
    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C-02-66-MR</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:41:32.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060896890005</udiDi>
    <basicUdiDi>506089689GIQUANTY2</basicUdiDi>
    <tradeName>05060896890005</tradeName>
    <deviceName>GIQuant</deviceName>
    <manufacturerName>Motilent Ltd.</manufacturerName>
    <manufacturerSrn>UK-MF-000043625</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11059092</emdnCode>
    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIQuant</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:35:11.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056849000010</udiDi>
    <basicUdiDi>5056849LMSGV</basicUdiDi>
    <tradeName>LiverMultiScan</tradeName>
    <deviceName>LiverMultiScan</deviceName>
    <manufacturerName>Perspectum Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016685</manufacturerSrn>
    <authorisedRepresentativeName>Perspectum Unipessoal Lda</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000009160</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11059082</emdnCode>
    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:01:33.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987670101632</udiDi>
    <basicUdiDi>4987670A0601RR</basicUdiDi>
    <tradeName>04987670101632</tradeName>
    <deviceName>Vantage Orian, Vantage Fortian, Vantage Elan</deviceName>
    <manufacturerName>Canon Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000013254</manufacturerSrn>
    <authorisedRepresentativeName>Canon Medical Systems Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010531</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>MRT-2020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:34.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260737640078</udiDi>
    <basicUdiDi>426073764KNE017G</basicUdiDi>
    <tradeName>mdknee - standalone</tradeName>
    <deviceName>mdknee</deviceName>
    <manufacturerName>mediaire GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010713</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11059092</emdnCode>
    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>007</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:06:57.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260737640023</udiDi>
    <basicUdiDi>426073764PRS01C9</basicUdiDi>
    <tradeName>mdprostate - standalone</tradeName>
    <deviceName>mdprostate</deviceName>
    <manufacturerName>mediaire GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010713</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11059092</emdnCode>
    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:06:56.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260737640009</udiDi>
    <basicUdiDi>426073764mbV4MB</basicUdiDi>
    <tradeName>mdbrain - standalone</tradeName>
    <deviceName>mdbrain</deviceName>
    <manufacturerName>mediaire GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010713</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11059092</emdnCode>
    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:06:55.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>42606855900050</udiDi>
    <basicUdiDi>426068559NEO315AL</basicUdiDi>
    <tradeName>neo315</tradeName>
    <deviceName>neo315</deviceName>
    <manufacturerName>Neoscan Solutions GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007899</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>neo315</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:58:18.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260590632654</udiDi>
    <basicUdiDi>426059063000006AJ</basicUdiDi>
    <tradeName>Transaflow Multi-APS 24h safety MR/CT mehrfach Füllsystem zur Kontrastmittelverabreichung</tradeName>
    <deviceName>Kontrastmittel-Applikations-Set 24h</deviceName>
    <manufacturerName>CARDEA GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006460</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050185</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2590401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:49:27.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056304456038</udiDi>
    <basicUdiDi>805630445ESA.MR0000002.PX</basicUdiDi>
    <tradeName>MRI EVOlution 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050102</emdnCode>
    <emdnDescription>OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>300090300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:46.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056304456342</udiDi>
    <basicUdiDi>805630445ESA.MR0000002.PX</basicUdiDi>
    <tradeName>MRI EVOlution 26</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050102</emdnCode>
    <emdnDescription>OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300100300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:47:46.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260487681406</udiDi>
    <basicUdiDi>426048768AccInterface_ID4</basicUdiDi>
    <tradeName>Accessory Interface for 13C/1H Breast Coil Array P-X04L-H16LE-030-02130-002</tradeName>
    <deviceName>Accessory Interface</deviceName>
    <manufacturerName>RAPID Biomedical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008285</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11059080</emdnCode>
    <emdnDescription>VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02368</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:42:42.533Z</lastUpdated>
  </row>
</eudamedExport>