<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04573596202173</udiDi>
    <basicUdiDi>457359620103000000000032R</basicUdiDi>
    <tradeName>AIRIS Vento</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</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>Flexible Body coil(S) MR-QFC-101N for AIRIS Vento</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:30.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>04573596202180</udiDi>
    <basicUdiDi>457359620103000000000032R</basicUdiDi>
    <tradeName>AIRIS Vento</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</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>Flexible Body coil(M) MR-QFC-102N for AIRIS Vento</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:30.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>04573596202197</udiDi>
    <basicUdiDi>457359620103000000000032R</basicUdiDi>
    <tradeName>AIRIS Vento</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</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>Flexible Body coil(L) MR-QFC-103N for AIRIS Vento</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:30.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>04573596202203</udiDi>
    <basicUdiDi>457359620103000000000052V</basicUdiDi>
    <tradeName>APERTO Lucent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</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>Flexible Body coil N(S) MR-QFC-81N for APERTO Lucent</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:30.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>04573596202210</udiDi>
    <basicUdiDi>457359620103000000000052V</basicUdiDi>
    <tradeName>APERTO Lucent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</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>Flexible Body coil N(M) MR-QFC-82N for APERTO Lucent</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:30.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>04573596202227</udiDi>
    <basicUdiDi>457359620103000000000052V</basicUdiDi>
    <tradeName>APERTO Lucent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</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>Flexible Body coil N(L) MR-QFC-83N for APERTO Lucent</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:30.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>04573596202531</udiDi>
    <basicUdiDi>457359620103000000000052V</basicUdiDi>
    <tradeName>APERTO Lucent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</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>Joint coil (ML) MR-JCR-82L for APERTO Lucent</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:30.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>04573596202548</udiDi>
    <basicUdiDi>457359620103000000000052V</basicUdiDi>
    <tradeName>APERTO Lucent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</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>Head coil MR-QHC-81RC for APERTO Lucent</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:30.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>04573596202555</udiDi>
    <basicUdiDi>457359620103000000000052V</basicUdiDi>
    <tradeName>APERTO Lucent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</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>Knee coil MR-QKC-83RC for APERTO Lucent</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:30.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>04573596202586</udiDi>
    <basicUdiDi>457359620103000000000032R</basicUdiDi>
    <tradeName>AIRIS Vento</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</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>Head coil R MR-QHC-101R for AIRIS Vento</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:30.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>04573596202593</udiDi>
    <basicUdiDi>457359620103000000000032R</basicUdiDi>
    <tradeName>AIRIS Vento</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</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>Knee coil R MR-QKC-101R for AIRIS Vento</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:30.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>04573596202609</udiDi>
    <basicUdiDi>457359620103000000000032R</basicUdiDi>
    <tradeName>AIRIS Vento</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</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>Open Body coil MR-IBC-103 for AIRIS Vento</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:14:30.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>04068151017403</udiDi>
    <basicUdiDi>0405686900131UK</basicUdiDi>
    <tradeName>MAGNETOM Flow.Ace S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Shenzhen Magnetic Resonance Ltd.</manufacturerName>
    <manufacturerSrn>CN-PR-000020467</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11571640</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T11:07:35.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>04068151017410</udiDi>
    <basicUdiDi>0405686900131UK</basicUdiDi>
    <tradeName>MAGNETOM Flow.Apex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Shenzhen Magnetic Resonance Ltd.</manufacturerName>
    <manufacturerSrn>CN-PR-000020467</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11571641</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T11:07:35.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>04068151051766</udiDi>
    <basicUdiDi>0405686900131UK</basicUdiDi>
    <tradeName>MAGNETOM Flow.Ace</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Shenzhen Magnetic Resonance Ltd.</manufacturerName>
    <manufacturerSrn>CN-PR-000020467</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11571132</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T11:07:17.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260675390042</udiDi>
    <basicUdiDi>426067539P01FK</basicUdiDi>
    <tradeName>smart-sync</tradeName>
    <deviceName></deviceName>
    <manufacturerName>northh medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005858</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P01-SB-01 (Lot 06)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:44:57.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260590633590</udiDi>
    <basicUdiDi>426059063000006AJ</basicUdiDi>
    <tradeName>DTS 250 Spiral CT + MRI MultiCSafe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CARDEA GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006460</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11050185</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T23:50:13.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260590633576</udiDi>
    <basicUdiDi>426059063000006AJ</basicUdiDi>
    <tradeName>DTS 200 Spiral CT + MRI MultiCSafe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CARDEA GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006460</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11050185</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105099</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T23:50:12.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260590633552</udiDi>
    <basicUdiDi>426059063000006AJ</basicUdiDi>
    <tradeName>DTS 150 CT + MRI MultiCSafe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CARDEA GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006460</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11050185</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105098</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T23:50:11.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260590633538</udiDi>
    <basicUdiDi>426059063000006AJ</basicUdiDi>
    <tradeName>DTS 100 CT + MRI MultiCSafe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CARDEA GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006460</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11050185</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105097</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T23:50:10.960Z</lastUpdated>
  </row>
</eudamedExport>